- Under the partnership, PACT Pharma will provide the company with insight into autologous NeoTCR manufacturing workflows to help identify product-market fit and secure early access to the technology for an undisclosed amount
- PACT Pharma is the second organization and first industry partner to join the program following Fred Hutchinson Cancer Research Center


**South San Francisco – January 8, 2021** – Cellares Corporation, a company focused on revolutionizing cell therapy manufacturing, announced that PACT Pharma, Inc., a clinical-stage company developing transformational personalized NeoTCR-T cell therapies for the eradication of solid tumors, has joined its Early Access Partnership Program (EAPP). PACT Pharma is the second collaborator and first industry organization to join its EAPP, following Fred Hutchinson Cancer Research Center. Under the terms of the agreement, PACT Pharma secured early access to Cellares’ technology for an undisclosed amount.

“PACT Pharma is a leading developer of cutting-edge personalized medicines. We are honored by the trust PACT Pharma is placing in Cellares’ team and technology to create a path to commercial scale manufacturing designed to be robust and cost-effective,” said Cellares co-founder and chief executive officer Fabian Gerlinghaus. “We look forward to working together to ensure we are creating a manufacturing platform that fits the needs of the industry at large and PACT Pharma in particular.”

As part of Cellares’ EAPP, PACT Pharma will provide the company with insight into autologous NeoTCR manufacturing workflows and participate in user studies. PACT Pharma will also provide feedback on Cell Shuttle hardware and software to inform user needs and contribute to product requirements and system specifications.

“Currently, no solution exists that scales to meet the needs of cell therapy manufacturers at every phase of the development and commercialization process,” said Tim Moore, president and chief operating officer of PACT Pharma. “PACT Pharma is excited to be working with Cellares and contribute to the future of cell therapy manufacturing. Cellares’ next-generation cell therapy platform is designed to enable closed, automated and scalable manufacturing of cell therapies like our autologous NeoTCR-T cell therapies. We seized the opportunity to weigh in on Cellares’ manufacturing platform while it's still in development, enabling PACT to potentially usher in a new future for cell therapy manufacturing.”

**About The Cell Shuttle**
The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run the exact processes specified for their cell therapy. Compared with currently available cell therapy manufacturing methods, this next-generation platform enables a three-fold reduction in process failure rates and is capable of
producing 10+ patient doses in parallel, which increases manufacturing scalability by an order of magnitude. This will reduce the per-patient manufacturing cost by up to 70 percent for most processes.

**About Cellares Corporation**
Cellares is creating the future of cell therapy manufacturing and accelerating access to life-saving cell therapies. The company is developing a one-of-a-kind solution to overcome the limitations associated with manufacturing cell therapies that are more affordable and widely available to patients in need. With Cellares’ proprietary platform—The Cell Shuttle—biopharma companies, academic research centers and CDMOs will no longer have to compromise by either choosing a manufacturing platform that is semi-automated but lacks workflow flexibility, or one that provides customization but not the end-to-end automation needed to manufacture at scale. The company is headquartered in South San Francisco, Calif. For more information visit [www.cellares.com](www.cellares.com).

**About PACT Pharma**
PACT Pharma is a clinical-stage biopharmaceutical company pioneering individualized, non-viral precision genome engineered, tumor-specific T cell therapies for the treatment of patients with solid cancers. PACT Pharma is now enrolling patients in its first-in-human Phase 1 clinical trial.
Each person's cancer emerges with a private signature of mutations. PACT Pharma identifies these cancer mutation targets (neoantigens) for each person, biochemically verifies and captures T cells from their blood and uses its proprietary, cutting edge (non-viral) precision genome engineering technologies to manufacture a personalized immune cell therapy product for each person with cancer.

**CONTACTS**

**Cellares**

For Media:
Sylvia Aranda
W2O Group
saranda@w2ogroup.com

For Potential Partners:
Mark Flower
Cellares Corporation
bd@cellares.com

**PACT Pharma**

Glover Park Group (GPG)
Sarah Sutton
ssutton@gpg.com
202-337-0808

Uneek Mehra
umehra@pactpharma.com

Cellares Adds PACT Pharma to its Early Access Partnership Program

Press Releases

- The round was led by Vida Ventures, a next generation life science venture firm with industry-leading experience in cell and gene therapy  
- The financing will be used to expand clinical & manufacturing development to deliver clinical data for patients with multiple solid tumor types  

SOUTH SAN FRANCISCO, Calif., Jan. 10, 2020 /PRNewswire/ — PACT Pharma, in pursuit of its vision to eradicate solid tumors using transformational, first-in-class fully personalized NeoTCR-T cell therapies, today announced that it has closed an oversubscribed $75 million Series C financing. This round, led by Vida Ventures, a next generation life science venture firm with industry-leading experience in the cell and gene therapy, also included current investors of PACT.  

Combined with proceeds from previous financings, PACT will use the Series C proceeds to expand the scope of its clinical plan to investigate NeoTCR-T cell products targeting multiple neoantigens for a spectrum of solid tumor types. In addition to clinical expansion, PACT will open in 2020 a next-gen GMP manufacturing facility in South San Francisco to support the end-to-end production and supply chain for the engineering of personalized neoantigen-targeted autologous T cells. Under the direction of industry veteran Tim Moore, President and Chief Technology Officer, PACT will leverage the new in-house manufacturing facility to automate manufacturing and analytic processes to reduce cycle time and manufacturing costs.  

“PACT has grown from company launch to opening its first-in-kind clinical trial in two years. Our progress has been exhilarating and the support from our existing investors has made that progress possible,” said Alex Franzusoff, PhD, Chief Executive Officer of PACT Pharma. “As we look to the next stage of our development and expansion of our clinical programs, we are excited to have interest from a new group of prominent investors who both understand the potential of NeoTCR-T cell therapy and have direct experience in the space. Vida Ventures stood out as a partner of choice, given their depth of operational experience in research, clinical development and manufacturing in cell therapy as well as their proven ability to guide companies like Kite and Allogene across key stages of development.  

As part of the Series C financing, Helen S. Kim, Managing Director at Vida Ventures, will join the Company’s Board of Directors. Ms. Kim brings over 25 years of biotechnology leadership experience and serves on the boards of Assembly Biosciences, Applied Molecular Transport, A2 Biotherapeutics and Exicure, Inc.  

“Our investment in PACT Pharma represents our goal to fund scientific advances by embracing cutting edge innovation with the potential to make a meaningful difference in the lives of patients,” said Kim. “PACT has developed a pioneering platform of personalized designer T cells with the potential to target some of the most elusive solid cancers facing society today.”  

PACT Pharma Raises $75M in Oversubscribed Series C Financing to Develop Fully Personalized NeoTCR-T Cell Therapies for Patients with Cancer

**South San Francisco – January 11, 2021** – PACT Pharma, Inc., a clinical-stage company developing transformational personalized neoTCR-T cell therapies for the eradication of solid tumors, today announced that the company will present at the 39th Annual J.P. Morgan Healthcare Conference, which is being held virtually, on January 11, 2021 at 7:30 a.m. PT/10:30 a.m. ET.  

**About PACT Pharma**

PACT is a clinical-stage biopharmaceutical company pioneering individualized, non-viral precision genome engineered, tumor-specific T cell therapies for the treatment of patients with solid cancers. PACT is now enrolling patients in its first-in-human Phase 1 clinical trial. 

Each person's cancer emerges with a private signature of mutations. PACT identifies these cancer mutation targets (neoantigens) for each person, biochemically verifies and captures T cells from their blood and uses its proprietary, cutting edge (non-viral) precision genome engineering technologies to manufacture a personalized immune cell therapy product for each person with cancer.

For more information please visit[ www.pactpharma.com]( www.pactpharma.com). 


**Media Contact**

Sarah Sutton
Finsbury Glover Hering (FGH)
[ssutton@fgh.com](mailto:ssutton@fgh.com) 
202-337-0808

**Investor Contact**

Uneek Mehra
[umehra@pactpharma.com](mailto:umehra@pactpharma.com)


PACT Pharma to Present at the 39th Annual J.P. Morgan Healthcare Conference

PACT is a visionary company pushing the frontiers of science, technology and medicine. We are creating T cell therapies to alter the course of cancer and meaningfully impact the lives of patients who urgently need breakthrough therapies. We are building a team of driven, talented and passionate individuals committed to bringing these novel personalized therapies to people living with cancer.

Join Us

PACT is a clinical stage company dedicated to engineering transformational T cell therapies by enabling each person’s immune response to eradicate their individual cancer.

Who We Are

PACT Pharma is an exciting, well-funded clinical stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient&rsquo;s individual tumor and engineering T cells to kill that specific tumor.If you desire a stimulating fast paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.&nbsp; We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!We are in the San Francisco bay area, the heart of the world&rsquo;s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.We are currently recruiting for Process Development Scientist reporting to the Director Manufacturing Development. This position will be based in South San Francisco.The candidate will lead experimental research projects in the process development team developing PACTs cell manufacturing process.&nbsp; Furthermore, they will interact closely with Scientists and Research Associates of PACT&rsquo;s manufacturing team for technology transfer. &nbsp;They will be actively performing experiments and should be highly proficient in state-of-the-art techniques for primary cell culture, cell analysis and related instrumentation. The candidate should enjoy operating in an exceptionally dynamic and cooperative environment.Responsibilities:<ul><li>Design, perform and analyze experimental process development studies to support the development of the next generation cell therapy manufacturing process</li><li>Interact closely with associated departments to support technology transfer to manufacturing</li><li>Support of regulatory submissions by authoring/reviewing study reports or CMC sections</li><li>Maintain rigor and quality of execution and documentation</li><li>Manage multiple process development projects cross-functionally and provide routine progress updates on timelines and deliverables</li><li>Give presentations within the department and to senior management with minimal supervision</li><li>May be expected to provide assistance to other research associate level team members</li></ul>Qualifications: &nbsp;<ul><li>PhD with experience in T cell biology (or related field) with 2+ years of experience</li><li>Prior cell therapy process development experience desired</li><li>Familiarity with cGMP requirements a plus</li><li>The candidate should be highly goal-driven and have demonstrated the ability to focus on time-sensitive objectives</li><li>Excellent organizational skills and should be able to communicate clearly and concisely, both verbally and in the form of written reports</li><li>Proven ability to work independently, as well as to collaborate with peers and work effectively in a fast-paced team-oriented environment</li></ul>PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.&nbsp;

Corporate (South San Francisco)

Process Development Scientist

PACT Pharma is an exciting, well-funded clinical-stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient&rsquo;s individual tumor and engineering T cells to kill that specific tumor.&nbsp;If you desire a stimulating fast-paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.&nbsp; We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!&nbsp;We are in the San Francisco bay area, the heart of the world&rsquo;s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.&nbsp;We are currently recruiting for a Production Specialist who will report to the Manufacturing Supervisor and continue advancing PACT&rsquo;s cutting edge engineered cell product. This will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives.&nbsp;Responsibilities:Under the supervision of the Supervisor/ Manager, the Production Specialist will have the opportunity to participate in both manufacturing processes of immunotherapy cell products within a GMP environment, with the main focus in Plasmid Manufacturing. The duties of this position will primarily consist of manufacturing plasmids including activities such as bacterial culture management, and downstream purification (Ion Exchange Chromatography, Hydrophobic Interaction Chromatography, Tangential Flow Filtration).&nbsp; Furthermore, you will be responsible for completing successful qualifications and ongoing support procedures for cleanroom operations and assisting in the development, writing, and review of SOPs, material specifications, standard manufacturing procedures, batch records, and other GMP documentation. The ideal candidate must have a collaborative and inquisitive nature, must possess excellent organizational and verbal and written communication skills, and be flexible in their working hours.&nbsp;&nbsp;<ul><li>Perform required processing and manipulations required to produce and assess safe and efficacious products</li><li>Proficiently functions within ISO cleanroom environments, ensuring personal and product safety</li><li>Operate with the proper aseptic technique when handling all product and materials</li><li>Consistently produce a high level of documentation accuracy and clarity</li><li>Perform programmed microbial operations using specific equipment and closed systems</li><li>Proficiently operate and maintain equipment according to designed procedures</li><li>Manipulate products according to established standard operating procedures and batch records</li><li>Participating in clinical trial support and studies may include but are not limited to sample preparation, sample shipping, media, and reagent preparation.</li><li>Conduct and complete investigations for deviations in a timely manner&nbsp;</li></ul>Qualifications:<ul><li>Bachelor&rsquo;s degree or associate degree in a biologics, biotechnology, or related field preferred</li><li>A minimum of 2 years of applicable experience in the life science industry or cGMP manufacturing</li><li>Experience working with bioreactors or fermentation operation preferred</li><li>Experience working with chromatography and filtration operation preferred</li><li>Aseptic processing and clean room experience required</li><li>Strong work ethic, methodical approach to new challenges</li><li>Must be able to work as a team, as well as independently with minimal supervision</li><li>Demonstrates tact and courtesy in dealing with others</li><li>Excellent organizational skills and attention to detail</li><li>Good verbal and written communication skills</li><li>Skills in Microsoft Office (Excel, Word) preferred</li><li>Able to adapt to company growth and evolving responsibilities</li><li>Ability to work a flexible schedule that may include nights, weekends, and/or holidays</li></ul>Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear. The employee is regularly required to climb or balance; stoop, kneel, or crouch. The employee is frequently required to lift and/or move up to 30 pounds. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo gloves must be used when working with liquid nitrogen.&nbsp;&nbsp;PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.

Production Specialist

PACT Pharma is an exciting, well-funded clinical-stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient&rsquo;s individual tumor and engineering T cells to kill that specific tumor.&nbsp;If you desire a stimulating fast-paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.&nbsp; We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!&nbsp;We are in the San Francisco bay area, the heart of the world&rsquo;s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.&nbsp;We are currently recruiting for a Senior Clinical Research Associate who will report to the Director of Clinical Operations and continue advancing PACT&rsquo;s cutting edge engineered cell product. This will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives.&nbsp;What you will do: (Responsibilities)The Clinical Research Associate (CRA) supports moderately complex clinical trial activities in support of the clinical trial team to ensure successful clinical trial execution. The CRS works closely with the Clinical Trial Manager to ensure site-related start-up through close-out activities are conducted in accordance with good clinical practice, regulatory requirements, and relevant SOP's. The CRA may assist with vendor oversight and management. They will identify issues in a timely manner and escalates to management as appropriate. The CRA may complete monitoring visit report review and perform co-monitoring to verify that the rights and well-being of human subjects are protected; that the reported trial data are accurate, complete, and verifiable from source documents; that the conduct of the clinical trial is in adherence to protocol, GCP/ICH, and SOPs. The CRA will ensure site enrollment metrics are closely tracked to identify risk and elevate as appropriate to support enrollment goals.&nbsp; The CRA will also oversee the receipt, approval, filing, and tracking of essential documents for the duration of the study.&nbsp;Minimal Qualifications:<ul><li>Must be local to the San Francisco bay area or willing to relocate to the bay area.</li><li>BA/BS/BSN in related life sciences field with prior experience with clinical research. Advanced degree preferred</li><li>5+ years of clinical research experience in pharmaceutical/drug development, with a preference for oncology or immunotherapy/cellular therapy experience</li><li>Experience in the preparation, monitoring, and execution of clinical studies is a plus</li><li>Ability to motivate clinical site personnel to maintain/accelerate timelines in order to achieve clinical operational milestones</li><li>Some understanding of medical/therapeutic area knowledge and medical terminology is a plus</li><li>Able to comply with safety standards and respect privacy and confidentiality</li><li>Superb verbal and written communication skills</li><li>Excellent organizational skills along with strong attention to detail</li><li>Track record of working successfully in a cross-functional team</li><li>Willingness and capability to work effectively in a smaller pharma company (i.e. willing to roll-up your sleeves as necessary to help get the job done)</li><li>Demonstrated ability to handle a high volume of highly complex tasks within a given timeline</li><li>Full training in Good Clinical Practice (GCP) guidelines and thorough knowledge of FDA regulations</li><li>Strong verbal and written communication skills</li><li>Willingness to travel domestically and internationally&nbsp; &nbsp;</li></ul>Preferred Qualifications: <ul><li>3+ years&rsquo; experience in the role of Clinical Research Associate Preferred Prior experience in immuno-oncology, personalized medicine, T cell therapy a plus</li><li>Prior experience in a hands-on early development role building out a department within a small organization a plus&nbsp;</li></ul>PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.&nbsp;Ability to motivate clinical site personnel to maintain/accelerate timelines in order to achieve clinical operational milestones &bull; Some understanding of medical/therapeutic area knowledge and medical terminology is a plus &bull;

Senior Clinical Research Associate

PACT Pharma&nbsp;is an exciting, well-funded clinical stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient&rsquo;s individual tumor and engineering T cells to kill that specific tumor.&nbsp;If you desire a stimulating fast paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.&nbsp; We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!&nbsp;We are in the San Francisco bay area, the heart of the world&rsquo;s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.&nbsp;We are currently recruiting for a Senior QC Associate who will help to continue advancing PACT&rsquo;s cutting edge engineered cell product. This will be a unique opportunity to make direct contribution to bringing novel personalized cell therapies to the clinic and impact patient lives.&nbsp;What you will do: (Responsibilities):The Sr. Quality Control Associate is responsible for performing testing following written procedure for personalized DNA vectors and/or human T cell therapy product release, stability, and process development.&nbsp; As member of the QC team, the Sr. QC Associate contributes to all aspects of the day to day laboratory operations.<ul><li>She/he is expected to maintain rigor and high quality of execution and documentation complying with all regulations. Conduct work in accordance with guidelines and requirements established by FDA Good Manufacturing Practices (cGMP), Code of Federal Regulations, and other regulatory agencies</li><li>She/he must be able to communicate clearly and concisely, both verbally and in the form of written reports, including drafting and review of protocols, SOPs, test records, change controls and regulatory documentation to support clinical development.</li><li>Identify and troubleshoot technical problems with equipment and analytical procedure.</li><li>Draft and execute analytical procedure qualification/validation protocols and write deviations, change control or OOS investigation reports.</li><li>Design and conduct studies to optimize and improve robustness of analytical procedures.</li></ul>&nbsp;Minimum Qualifications:<ul><li>The ideal candidate should hold a Bachelor&rsquo;s degree in biological sciences, biotechnology or related field of study with 5+ years&rsquo; experience, or hold a Master&rsquo;s degree Biotechnology or related field of study with 4+ year experience in a QC laboratory.</li><li>Hands on experience with PCR, Agarose gel electrophoresis, immunoassays, and other molecular biology methodologies in a GMP/GLP laboratory, including qualification/validation.</li><li>Experience performing stability, in-process and release product testing in a GxP labortory</li><li>She/he must have experience in creating/editing documents such as SOPs, deviations, OOS, test procedures, batch records and regulatory documentation to support clinical development.</li><li>She/he is expected to maintain rigor and high quality of execution and documentation.</li><li>She/he must be able to work independently on projects and write detailed reports, perform data trending, work with LIMS system.</li><li>Candidate should enjoy operating in an exceptionally dynamic and cooperative environment that is goal-driven to achieve time-sensitive objectives.</li></ul>PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.

Senior Quality Control Associate

PACT Pharma is an exciting, well-funded clinical-stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient&rsquo;s individual tumor and engineering T cells to kill that specific tumor.&nbsp;If you desire a stimulating fast-paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.&nbsp; We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!&nbsp;We are in the San Francisco bay area, the heart of the world&rsquo;s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.&nbsp;We are currently recruiting for a Senior QC Associate who will help to continue advancing PACT&rsquo;s cutting edge engineered cell product. This will be a unique opportunity to make a direct contribution to bringing novel personalized cell therapies to the clinic and impact patient lives.&nbsp;What you will do: (Responsibilities):The Senior QC Associate is responsible for performing testing following written procedures for personalized DNA vectors and human T cell therapy product release, stability, and process development.&nbsp; As a member of the QC team, the Senior QC Associate contributes to all aspects of the day to day laboratory operations and creating and implementing laboratory operations systems and procedures, to assure the QC laboratory complies with all regulatory requirements.<ul><li>She/he is expected to maintain rigor and high quality of execution and documentation complying with all regulations. Conduct work in accordance with guidelines and requirements established by FDA Good Manufacturing Practices, Code of Federal Regulations, and other regulatory agencies</li><li>She/he must be able to communicate clearly and concisely, both verbally and in the form of written reports, including drafting and review of protocols, SOPs, batch records, and regulatory documentation to support clinical development.</li><li>Identify and troubleshoot technical problems with equipment and analytical procedure.</li><li>Draft and execute analytical procedure qualification/validation protocols and write reports.</li><li>Design and conduct studies to optimize and improve the robustness of analytical procedures.&nbsp;</li></ul>Minimum Qualifications:<ul><li>The ideal candidate should hold a Bachelor&rsquo;s degree in biological sciences, biotechnology, or related field of study with 4+ years&rsquo; experience, or hold a Master&rsquo;s degree in Biotechnology or related field of study with 2+ years experience in a similar QC role.</li><li>Highly experienced as a Quality Control Associate with in-depth knowledge of PCR, immunoassay, and/ or flow cytometry methodology for GMP and GLP use, including qualification/validation,.</li><li>She/he is expected to maintain rigor and high quality of execution and documentation.</li><li>The candidate should enjoy operating in an exceptionally dynamic and cooperative environment that is goal-driven to achieve time-sensitive objectives.</li><li>She/he is highly dedicated to mentor team individuals, motivating team success, and contributing in a collegial manner to the entire company.</li><li>She/he must be able to communicate clearly and concisely, both verbally and in the form of written reports, including drafting and review of protocols, SOPs, batch records, and regulatory documentation to support clinical development.&nbsp;</li></ul>PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.

PACT Pharma is an exciting, well-funded clinical stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient&rsquo;s individual tumor and engineering T cells to kill that specific tumor. In principle, this technology can be used to treat any cancer type.&nbsp;We are in the San Francisco bay area, the heart of the world&rsquo;s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.&nbsp;We are about eradicating cancer, come join our team!We are currently recruiting for a Scientist-level independent contributor who will join the Gene Editing team&rsquo;s research group and contribute to the advancement of PACT&rsquo;s cutting edge engineered cell product. This will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives.&nbsp;What You Will Do:You will be responsible for proposing projects, designing experiments, and executing work aimed at improving PACT&rsquo;s cellular product using genetic tools. The incumbent will draw on a deep understanding of T cell biology and oncology, as well as existing therapeutics MoAs, in order to contribute to the team&rsquo;s discussion of which genes or systems should be prioritized and how best to tailor cells to take advantage of the target pathway. In addition to target or screen proposal, molecular construct design and validation, data analysis, and regulatory report generation will be key components of your work.Minimal Qualifications:<ul><li>PhD plus at least 2 years&rsquo; post-graduate industry experience</li><li>Demonstrated autonomy in expression vector design and generation</li><li>Experience in areas related to T cell signaling or Immuno-Oncology as it relates to T cells</li><li>Ability to propose new projects, design proof of concept experiments, and independently execute and analyze the work</li><li>The candidate should be highly goal-driven and have demonstrated the ability to effectively prioritize and focus on time-sensitive objectives&nbsp;</li></ul>Preferred Qualifications: <ul><li>Direct experience drafting technical reports and documents for inclusion in regulatory submissions</li><li>A deep understanding of natural and synthetic gene regulatory elements that act at the DNA, RNA, and protein levels</li><li>Expertise in cutting-edge gene editing technologies and/or therapeutic cell products, and analysis methods for engineering outcomes</li><li>Ability to select and utilize informatics tools for analyzing large and/or complex datasets such as NGS, and correlating data with a variety of variables and outcomes.</li><li>Experience designing and conducting novel genetic screens</li></ul>PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.

Scientist - R&D

PACT Pharma is an exciting, well-funded clinical-stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient&rsquo;s individual tumor and engineering T cells to kill that specific tumor.&nbsp;If you desire a stimulating fast-paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.&nbsp; We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!&nbsp;We are in the San Francisco bay area, the heart of the world&rsquo;s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.&nbsp;We are currently recruiting for a Senior Research Associate in our Process Development department who will report to the Director, Manufacturing Development, and continue advancing PACT&rsquo;s cutting edge engineered cell product. This will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives.&nbsp;The person in this role will be responsible for performing experiments for continuous optimization of PACT&rsquo;s cell manufacturing process. He/she will interact closely with scientists and other research associates to evaluate potential process improvements and transfer the technology from small scale research to large scale processes.&nbsp;The ideal candidate will have experience in working with primary human T cells. She/he will be actively performing experiments and should be highly proficient in state of the art techniques for cell culture. &nbsp;The candidate should enjoy operating in an exceptionally dynamic and cooperative environment.Responsibilities:<ul><li>Perform small-scale and large-scale process development experiments using cell enrichment, cell engineering, cell expansion, formulation, and cryopreservation methods &nbsp;</li><li>Perform cell characterization using flow cytometry and cell-based assays</li><li>Evaluate new cell therapy technologies</li><li>Analyze data and write reports</li><li>Participate in technology transfers to the manufacturing team</li><li>Assist in the administration of complex processes by creating systems for managing workflows, resources, and materials</li></ul>Qualifications:<ul><li>The ideal candidate should hold a bachelor&rsquo;s degree with 5+ years&rsquo; experience, or hold a master&rsquo;s degree with 3+ year of experience</li><li>Must have experience in primary human cell culture techniques</li><li>Experience with large/clinical scale instrumentation for cell therapy is preferred</li><li>Experience with flow cytometry desired</li><li>Must be well-organized, GMP or GMPI-like laboratory experience a plus</li><li>Highly goal-driven and have demonstrated the ability to focus on time-sensitive objectives.</li><li>Ability to communicate clearly and concisely, both verbally and in the form of written reports.&nbsp;</li></ul>PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.

Senior Research Associate – Process Development

Associate Director, Computer Validation Systems and Data Integrity PACT Pharma is an exciting, well-funded clinical stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient&rsquo;s individual tumor and engineering T cells to kill that specific tumor. If you desire a stimulating fast paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.&nbsp; We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer! We are in the San Francisco bay area, the heart of the world&rsquo;s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants. We are currently recruiting for an Associate Director, Computer Validation Systems and Data Integrity who will continue advancing PACT&rsquo;s cutting edge engineered cell product. This will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives. This individual will be responsible for software quality oversight and execution of system validation and verification efforts supporting computerized systems (including equipment/instruments with a computer component) ensuring compliance to quality objectives and regulatory requirements. Responsibilities:<ul><li>Provide Software QA and validation leadership for GXP computerized systems and applies risk-based methodology to validation/qualification efforts in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5</li><li>Oversee and execute software QA and validation strategy in support of custom software systems, COTS configuration, workflow, and/or analytics to improve the overall accuracy, efficiency, and effectiveness of the electronic computerized system</li><li>Manage and provide guidance to system testing personnel in the organizing and prioritizing daily tasks, performing training, and writing performance reviews</li><li>Effectively identify and resolve complex system issues and appropriately communicates gating items to senior management and stakeholders</li><li>Participate and support the external audit program for vendors related to GXP computerized systems</li><li>Participate and be the Software QA and Computer system validation SME in cross-functional project teams</li><li>Evaluate and recommend QA process changes by keeping abreast of the requirements for compliance in own area of work</li><li>Provide training on regulatory issues affecting own area of work</li></ul>Qualifications:<ul><li>B.S. degree in Computer Science or related field with 10+ years of relevant progressive experience, preferably within the pharmaceutical/biotech industry</li><li>At least 5 years of supervisory/personnel management experience</li><li>Comprehensive expertise and working knowledge of GxP, 21 CFR Parts 11 compliance requirements</li><li>Experience in providing oversight in implementing and maintaining GXP computer systems in a validated state</li><li>Strong working knowledge in validation methodology (including GAMP) and software development life cycle (SDLC) principles</li><li>Proven experience managing software validation teams</li><li>Proven experience developing automated test systems and scripts beyond record and playback. Specifically developing functions, adding control flow logic, loops etc.</li><li>Demonstrated experience with Selenium, Cucumber, or similar</li><li>Extensive experience with testing framework e.g. Junit, TestNG</li><li>Excellent verbal, written and interpersonal communication skills</li><li>Effective time management and interpersonal skills</li><li>Strong organizational skills, planning skills and must work effectively within teams.</li><li>Must work effectively within teams with rapidly changing priorities</li></ul>PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.&nbsp;&nbsp;

Associate Director, Computer Systems Validation and Data Integrity

PACT Pharma is an exciting, well-funded clinical stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient&rsquo;s individual tumor and engineering T cells to kill that specific tumor.&nbsp;If you desire a stimulating fast-paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.&nbsp; We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!&nbsp;We are in the San Francisco bay area, the heart of the world&rsquo;s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.&nbsp;We are currently recruiting for a Senior Manager, Laboratory Operations who will initially report to the Director of imPACT and anchor a newly formed production team focused on operationalizing PACT&rsquo;s cutting edge engineered cell product. This will be a unique opportunity to design and implement new operational processes and see your contributions to PACT&rsquo;s personalized therapy directly translate into the clinic and impact patient lives.The person in this role will be responsible for processing of clinical blood samples for the identification and isolation of patient private NeoE-specific T cells, as part of product selection for the manufacture of the adoptive cell therapy product (neoTCR-P1) for our clinical patients. This process is performed in a GMP-like laboratory setting and includes flow cytometry, RT-PCR, and Next-generation Sequencing (NGS) analysis of single T cells. The ideal candidate should enjoy operating in an exceptionally dynamic and cooperative environment.Responsibilities:<ul><li>Lead, mentor, and grow a team of scientists and research associates responsible for processing clinical blood samples for the identification and isolation of patient NeoE-specific T cells in our clinical trial.</li><li>Serve as the sole point of contact and process owner for the imPACT portion of PACT&rsquo;s production pipeline.</li><li>Define and implement operational protocols and best practices.</li><li>Manage workflows, materials, and resources to ensure the quality and timely delivery of patient-specific reagent libraries, DNA NGS libraries, and FACS based blood analysis.</li><li>Oversee processes to identify and implement process improvements focused on quality, turnaround time, and cost.</li><li>Collaborate with process development and engineering to scale your operation by automating wherever possible.</li><li>Author SOPs and work instructions in accordance with PACT&rsquo;s quality management system and provide data for regulatory documentation to support clinical development.</li></ul><ul><li>Lead efforts to analyze data and write reports to inform therapeutic candidate selection for our clinical patients.</li></ul>Qualifications:<ul><li>Bachelor&rsquo;s or master&rsquo;s degree with 6+ years of experience or Ph.D. with 3+ years of industry experience with a career focus in cell or molecular biology, biochemistry, or molecular genetics.</li><li>3+ years&rsquo; experience managing a production laboratory operation</li><li>Experience with at least two of: single-cell technologies, FACS, RT-PCR, next-gen sequencing, laboratory automation.</li><li>Experience operating within a formal quality management system. cGMP or ISO 13485 production experience is a plus.</li><li>Communicate clearly and concisely, both verbally and in the form of written reports.</li><li>Demonstrated leadership skills and teamwork.</li><li>Demonstrated ability to implement laboratory best practices, continuous improvement methodologies, and lean manufacturing principles.</li><li>Highly goal-driven and have demonstrated the ability to focus on time-sensitive objectives.</li><li>Experience with immuno-oncology or T cell biology is a plus.</li><li>Experience in a turnaround time-sensitive production environment is a plus.</li><li>Experience with complex LIMS, informatics, or data management is a plus.</li></ul>&nbsp;PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.

Senior Manager, Laboratory Operations, imPACT

PACT Pharma is an exciting, well-funded clinical-stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient&rsquo;s individual tumor and engineering T cells to kill that specific tumor.&nbsp;If you desire a stimulating fast-paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.&nbsp; We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!&nbsp;We are in the San Francisco bay area, the heart of the world&rsquo;s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.&nbsp;We are currently recruiting for a Scientist II in the imPACT clinical pipeline group who will initially report to the Director of imPACT to continue advancing PACT&rsquo;s cutting edge engineered cell product. This will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives.The person in this role will be responsible for leading a team to process clinical blood samples for the identification and isolation of patient NeoE-specific T cells, as part of the product selection process prior to the manufacturing of PACT's adoptive cell therapy product (neoTCR-P1) for patients. This process is performed in a GMP-like laboratory setting and includes flow cytometry, RT-PCR, and Next-generation Sequencing (NGS) analysis of single T cells. The candidate would participate in process development and continuous improvement activities to reduce turnaround time and cost while improving the robustness of the imPACT isolation technology. The ideal candidate should enjoy operating in an exceptionally dynamic and cooperative environment.Responsibilities:<ul><li>Process clinical blood samples for the identification and isolation of patient NeoE-specific T cells to advance PACT&rsquo;s neoTCR-P1 clinical trial</li><li>Construct patient-specific reagent libraries</li><li>Utilize FACS machines to analyze patient blood samples</li><li>Carry out experiments to generate DNA library for NGS</li><li>Analyze data and write reports to inform therapeutic candidate selection for our clinical patients</li><li>Identify and implement process improvements focused on quality, turnaround time, and cost</li><li>Implement and operate advanced liquid handling and robotic laboratory automation</li><li>Become a process expert and mentor/train research associates in performing the workflows</li><li>Partner with Research and Development teams to run research samples, custom workflows, and validation studies</li></ul>Qualifications:<ul><li>Ph.D. with 2 to 5 years of industry experience preferably in a production environment</li><li>Experience with single-cell technologies, FACS, and next-gen sequencing</li><li>Experience with immuno-oncology or T cell biology</li><li>Ability to propose new projects, design proof of concept experiments, and lead the execution and analysis of the work</li><li>Highly goal-driven and the ability to handle delicate experiments</li><li>Experience operating within a formal quality management system. cGMP or ISO 13485 production experience is a plus</li><li>Communicate clearly and concisely, both verbally and in the form of written reports</li><li>Demonstrated leadership skills and teamwork</li><li>Experience working with laboratory automation and liquid handlers is a plus</li><li>This position will require flexible work schedules (Shift schedules)&nbsp;&nbsp;</li></ul>PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.&nbsp;

Scientist II, imPACT Clinical Pipeline

PACT Pharma&nbsp;is an exciting, well-funded clinical-stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient's individual tumor and engineering T cells to kill that specific tumor.&nbsp;&nbsp;&nbsp;If you desire a stimulating fast-paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.&nbsp; We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!&nbsp;&nbsp;We are in the San Francisco bay area, the heart of the world's premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.&nbsp;&nbsp;&nbsp;We are currently recruiting for a Process Development Scientist II,&nbsp;in the protein sciences department specializing in automation &amp; process development who will report to a Senior Scientist in Protein Sciences or the Head of the department and continue advancing PACT's patient-specific product development pipeline. The incumbent should be creative and interdisciplinary with practical problem-solving skills and hands-on experience in the areas of process development, automation and liquid handling, as well as molecular cloning and protein expression/ purification. This will be a unique opportunity to see your solutions transform the way we process patient samples, improving PACT&rsquo;s throughput and turnaround time of our personalized process and directly impact patient lives.&nbsp;&nbsp;Responsibilities:&nbsp;<ul><li>Work with the Protein Sciences process staff to&nbsp;identify potential improvements to the protein production pipeline, propose innovative solutions,&nbsp;assess the impact of modifications, and lead the implementation of new workflows</li><li>Design, plan and execute key wet lab proof of concept experiments to improve reproducibility, quality, and scalability of the processes</li><li>Validate&nbsp;and tune&nbsp;new processes, draft process documents, and work with process staff to implement the changes</li><li>Partner closely with the Automation and Software Development groups, acting&nbsp;as the technical&nbsp;project lead&nbsp;to identify, prioritizes, and track&nbsp;projects&nbsp;&nbsp;</li></ul>Qualifications:&nbsp;<ul><li> Ph.D. or equivalent plus at least&nbsp;5&nbsp;years' industry experience developing, validating, and implementing automation workflows, ideally involving liquid handlers</li><li>Ability to propose new projects, design proof of concept experiments, and lead the execution and analysis of the work</li><li>Hands-on experience with mammalian cell culture, and high-throughput protein synthesis workflows</li><li> Experience working with scripts to integrate and control automation equipment</li><li> Experience with technology transfer and supporting your&nbsp;production&nbsp;processes after launch</li><li> Experience&nbsp;developing and launching&nbsp;solutions within a regulated environment</li><li>Highly goal-driven and have demonstrated the ability to effectively prioritize and focus on time-sensitive objectives&nbsp;</li></ul>Preferred Qualifications:&nbsp;&nbsp;<ul><li>Experience with high-throughput molecular cloning workflows</li><li>Experience with high-throughput DNA and protein analysis&nbsp;</li></ul>PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate&nbsp;on the basis of&nbsp;race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.&nbsp;

Process Development Scientist II – High Throughput

PACT Pharma is an exciting, well-funded clinical-stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient's individual tumor and engineering T cells to kill that specific tumor.&nbsp;If you desire a stimulating fast-paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team. We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!&nbsp;We are in the San Francisco bay area, the heart of the world's premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.&nbsp;We are currently recruiting for a Scientist II in the Tumor Immunology clinical pipeline group. The person in this role will be responsible for performing immunological assays to functionally characterize the patient NeoE-specific T cells, as part of the product selection process prior to the manufacturing of PACT's adoptive cell therapy product (neoTCR-P1). This process is performed in a GMP-like laboratory setting. The candidate should enjoy operating in an exceptionally dynamic and cooperative environment and will communicate results to and coordinate efforts with a larger cross-disciplinary team of immunologists, biologists, engineers, and bio-informaticians.&nbsp;Responsibilities:<ul><li>Perform and thoroughly document ex vivo T cell functional assays according to established procedures.</li><li>Aid in drafting new protocols, improving existing workflows, and provide data for regulatory filings to support clinical development.</li><li>Analyze data and write reports to inform therapeutic candidate selection for our clinical patients</li><li>Identify and implement process improvements focused on quality, turnaround time, and cost</li><li>Implement and operate advanced liquid handling and robotic laboratory automation</li><li>Become a process expert and mentor/train research associates in performing the workflows</li><li>Partner with Research and Development teams to run research samples, custom workflows, and validation studies</li></ul>Qualifications:<ul><li>Ph.D. with 2 to 5 years of industry experience preferably in a production environment</li><li>Highly proficient in state-of-the-art techniques for characterizing T cell phenotype and measuring T cell functionality (antigen-specific killing assays, cytokine production, proliferation).</li><li>Experience with flow cytometry and primary human T cells is a must.</li><li>Experience operating within a formal quality management system. cGMP or ISO 13485 production experience is a plus</li><li>Communicate clearly and concisely, both verbally and in the form of written reports</li><li>Demonstrated leadership skills and teamwork</li><li>The candidate should be able to focus on deliverables and have demonstrated the ability to prioritize time-sensitive objectives.</li><li>Experience working with laboratory automation and liquid handlers is a plus</li><li>This position will require flexible work schedules.</li></ul>&nbsp;PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.&nbsp;

Scientist II, Tumor Immunology Clinical Pipeline

PACT Pharma is an exciting, well-funded clinical stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient&rsquo;s individual tumor and engineering T cells to kill that specific tumor.  &nbsp;If you desire a stimulating fast paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.  We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!  &nbsp;We are in the San Francisco bay area, the heart of the world&rsquo;s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.  &nbsp;We are currently recruiting for&nbsp;an&nbsp;Engineer&nbsp;specializing in&nbsp;tech transfer and&nbsp;service support for automated systems who will report to the Director of Production Engineering to help to continue advancing PACT&rsquo;s patient-specific product development pipeline. The incumbent should be creative and interdisciplinary with practical problem-solving skills and hands-on experience in the areas of laboratory automation, liquid handling, and instrumentation qualification and validation. This will be a unique opportunity to see your solutions transform the way we process patient samples, improving PACT&rsquo;s throughput and turnaround time, and directly impact patient lives.  &nbsp;What You Will Do: &nbsp;The incumbent will draw on their experience in laboratory automation service and support to maintain and improve automated production processes across a range of scientific disciplines and throughout the company. This individual will need to have experience with liquid handling and laboratory automation principals and be able to identify issues and implementation solutions. He or she will partner closely with scientific subject matter experts as well as automation, software, and process engineers to continue to scale and streamline PACT&rsquo;s processes.  &nbsp;Responsibilities will include: &nbsp;<ul><li>Working on cross functional teams to develop and improve automated processes&nbsp;&nbsp;</li><li>Performing regular maintenance, calibration, and troubleshooting procedures on liquid handlers, lab equipment, and integrated systems &nbsp;</li><li>Writing and performing verification and validation test protocols and reports including IQ/OQ/PQ&nbsp;</li><li>Performing Operator training&nbsp;</li><li>Improving tools, reporting, and operational documents for tracking spare parts, service calls, and repair decision- making&nbsp;</li></ul>Minimal Qualifications: &nbsp;<ul><li>BS degree with a minimum of&nbsp;3&nbsp;years industry experience supporting production laboratory operations&nbsp;</li><li>2&nbsp;+ years hands-on experience focused on service and support of liquid handlers (Hamilton, Tecan, Beckman, Agilent etc.) and integrated automation solutions&nbsp;</li><li>Familiarity with of the principles of continuous process improvement (Lean, Six Sigma, or QbD) &nbsp;</li><li>Experience working in a regulated environment (GxP/CLIA/CAP) &nbsp;</li><li>Highly goal-driven and have demonstrated the ability to effectively prioritize and focus on time-sensitive objectives&nbsp;</li></ul>Preferred Qualifications:  &nbsp;<ul><li>MS or PhD with a minimum of&nbsp;5&nbsp;years of production equipment service support &nbsp;</li><li>Service support experience with integrated systems and multiple liquid handling platforms: Hamilton, Tecan, Beckman, Agilent etc. &nbsp;</li><li>3&nbsp;+ years of experience investigating, developing, and implementing complex laboratory or manufacturing processes&nbsp;&nbsp;</li><li>Experience with instrument integrations and scheduling software&nbsp;&nbsp;</li><li>Experience programming in python, Perl, C#, or similar&nbsp;&nbsp;</li><li>Experience with of the principles of continuous process improvement (Lean, Six Sigma, or QbD) &nbsp;</li><li>Experience deploying hardware into production environments with robust validation/verification requirements (cGMP, CLIA, CAP, ISO 13485) and stringent IQ/OQ/PQ   &nbsp;</li><li>Hands-on experience with bacterial and/or mammalian cell culture, protein and nucleic acid purification, microfluidics, and genome engineering platforms (e.g. CRISPR, TALENs). &nbsp;</li></ul>PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status. &nbsp;

Engineer, Production Engineering

Senior Research Associate &ndash;Developmental Analytics &nbsp; PACT Pharma is an exciting, well-funded clinical stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient&rsquo;s individual tumor and engineering T cells to kill that specific tumor.If you desire a stimulating fast paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.&nbsp; We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!We are in the San Francisco Bay Area, the heart of the world&rsquo;s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.We are currently recruiting for a Senior Research Associate in Developmental Analytics who will report to the Senior Developmental Analytics Scientist within the Process Development department. This position will be based in South San Francisco.The successful candidate will be responsible for performing routine assays required to assess continuous process optimization of PACT&rsquo;s cell manufacturing process. In addition, they will also assist in the optimization of current analytical assays or development of new analytical assays in order to better characterize the manufacturing process, potential process improvements, or the final cell therapy product. This role will involve close interaction with Scientists and Research Associates of PACT&rsquo;s Process Development team, other R&amp;D teams, and the manufacturing team, e.g. QC, for technology transfer. The ideal candidate will have experience in working with cell and molecular biology assays, e.g. flow cytometry and ELISA. &nbsp;The candidate should enjoy operating in an exceptionally dynamic and cooperative environment.Responsibilities:<ul><li>Perform routine cell characterization using flow cytometry and cell-based assays</li></ul><ul><li>Administration of complex processes by creating systems for managing workflows, resources, and materials</li></ul><ul><li>Assist in the development and qualification of quantitative or semi-quantitative bioanalytical and molecular methods to support the current and next generation cell therapy manufacturing processes</li><li>Participate in technology transfers to the QC team</li><li>Analyze data and write reports</li></ul>Qualifications:<ul><li>The ideal candidate should hold a bachelor&rsquo;s degree with 5+ years&rsquo; experience, or hold a master&rsquo;s degree with 3+ year experience</li><li>Must have experience in primary human cell culture and aseptic techniques</li><li>Must have experience with flow cytometry</li><li>Experience with the following molecular biology assays is preferred: ELISA, MSD, qPCR, ddPCR</li><li>Experience with T cell biology is desired</li><li>Must be well-organized, GMP or GMP-like laboratory experience a plus</li><li>Highly goal-driven and have demonstrated the ability to focus on time-sensitive objectives</li><li>Ability to communicate clearly and concisely, both verbally and in the form of written reports</li></ul>PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.

Senior Research Associate –Developmental Analytics

<a href="http://www.pactpharma.com">www.pactpharma.com</a>

Open House

Senior Research Associate &ndash; Tumor Immunology&nbsp;PACT Pharma&nbsp;is an exciting, well-funded clinical-stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient's individual tumor and engineering T cells to kill that specific tumor.&nbsp;If you desire a stimulating fast-paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.&nbsp; We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!&nbsp;We are in the San Francisco bay area, the heart of the world's premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.&nbsp;We are currently recruiting for a Senior Research Associate in Tumor Immunology&nbsp;who will report to the Scientist and continue advancing PACT&rsquo;s cutting edge engineered cell product. This will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives.&nbsp;What you will do:&nbsp;The person in this role will be responsible for performing immunological assays and contributing to discovery research programs for next-generation T cell therapies for cancer. The candidate should enjoy operating in an exceptionally dynamic and cooperative environment and will collaborate with a larger cross-disciplinary team of immunologists, biologists, engineers, and bio-informaticians.&nbsp;Responsibilities:<ul><li>Perform ex vivo T cell functional assays according to established procedures</li><li>Perform flow cytometry, ELISA, cell culture, and other cell-based assays</li><li>Experience with molecular biology</li><li>Contribute to generating pre-clinical data to support IND filing</li><li>Accurately document experimental procedures and data in electronic lab notebooks</li><li>Analyze and compile data; communicate research findings to the group and company in the form of written reports and/or oral presentations&nbsp;</li></ul>Minimum Qualifications:<ul><li>Bachelor&rsquo;s or Master&rsquo;s degree in Immunology, Cell or Molecular Biology, Genetics, Biology, Biochemistry, or related discipline</li><li>2+ years of experience if holding a master&rsquo;s degree and 3+ years of experience if holding a bachelor&rsquo;s degree</li><li>Experience with culturing primary human cells and/or cell lines</li><li>Experience with flow cytometry, ELISA, and cell-based assays</li><li>Able to follow detailed procedures</li><li>Ability to focus on deliverables and have demonstrated the ability to prioritize time-sensitive objectives</li><li>Adept at working independently and in a collaborative team environment</li><li>Excellent organizational skills and able to communicate clearly and concisely, both verbally and in the form of written reports&nbsp;</li></ul>Preferred Qualifications:<ul><li>Working knowledge of common molecular techniques such as PCR, cloning, RNA extraction and CRISPR/Cas9</li><li>Experience with R/Python and analysis of large scale transcriptomic and epigenetic datasets (e.g. from scRNAseq, ATAC-seq, and/or CITE-seq)</li></ul>PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.

Senior Research Associate -  Tumor Immunology

Senior Director, Statistical Programming PACT Pharma&nbsp;is an exciting, well-funded clinical stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient&rsquo;s individual tumor and engineering T cells to kill that specific tumor. In principle, this technology can be used to treat any cancer type.If you desire a stimulating fast paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.&nbsp; We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!We are in the San Francisco bay area, the heart of the world&rsquo;s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.We are currently recruiting for a Senior Director, Statistical Programming who will report to VP, Biometrics and continue advancing PACT&rsquo;s cutting edge engineered cell product.Responsibilities:<ul><li>Lead a team to produce statistical outputs and reports for clinical study teams</li><li>Adopt and propose strategic approach to producing and prioritizing analytical deliverables, incorporating innovative tools and methods where needed</li><li>Analyze and present data as well as make recommendations to&nbsp;a diverse group of colleagues from different backgrounds and areas of expertise</li><li>Design or establish standards, tools, and processes that improve the efficiency of producing analytics across molecule programs</li><li>Lead internal study management team members, bio-sample operation managers and external data vendors to define file format specifications and data transfer specifications for all non-CRF data collection and transfers to internal data operating systems or specific biomarker data repositories</li><li>Develop or review the data quality check specifications and generate programs using SAS or Tableau to check the data quality and flag data issues for both non-CRF and CRF data</li><li>Generate visualization report for data quality check or medical data review</li><li>Understand the nature of non-CRF data and define file format specifications and file transfer specifications following company standard</li><li>Ensure the quality of non-CRF data are meeting study needs</li><li>Ensure that clinical outputs are generated in a reproducible manner</li></ul>Qualifications:<ul><li>BS/MS preferably in Data Science related field (e.g. Statistics, Mathematics, Epidemiology, Health Economics, Computer Science, Bioinformatics, etc.)&nbsp;with 15+ years of&nbsp;experience&nbsp;preferably&nbsp;in analysis of clinical trial data</li><li>Experience on clinical programming with solid experience in database creation, SAS programming, Spotfire etc. Experience with Tableau and R is a plus</li><li>Ability to learn quickly and adapt to new environment is highly desirable</li><li>Extensive knowledge and experience on clinical lab data or biomarker data are highly desired</li><li>Experience managing and providing strategic guidance to the biostatics team members</li><li>Excellent problem solving and analytical skills</li><li>Excellent verbal and written communication skills</li><li>Excellent collaborative and team-working skills, as demonstrated by working collaboratively with colleagues in other technical disciplines</li><li>Proven competence of development of software under a Software Development Lifecycle (SDLC).</li><li>Highly&nbsp;experienced in the use of statistical software, primarily SAS and/or R, and can readily learn new software applications.</li></ul>PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.&nbsp;

Senior Director, Statistical Programming

PACT Pharma is an exciting, very well-funded clinical-stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient&rsquo;s individual tumor and engineering T cells to kill that specific tumor. If you desire a stimulating fast-paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team. We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer! We are in the San Francisco bay area, the heart of the world&rsquo;s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants We are currently recruiting for a Process Engineer who will report to the Associate Director, Manufacturing Sciences and Technology (MSAT), and continue advancing PACT&rsquo;s cutting edge engineered cell product. This will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives. This position is responsible for supporting the activities involved in process transfers, compliance, and scalability for PACT&rsquo;s cell and plasmid manufacturing operations. Team members will focus on technology transfers from Process Development into GMP manufacturing facilities as well as driving and developing process automation and scalability solutions to improve process reliability, safety, cost-effectiveness, and compliance. It is expected that the Process Engineer will work closely with other corporate functional areas as well as outside vendors to ensure deliverables are met. Responsibilities:<ul><li>Manage the transfer of manufacturing processes from Process Development or external sites into the PACT GMP facility</li><li>Develop integration solutions for the manufacturing process and data management, including DCS, SCADA, MES, QMS, and LIMS</li><li>Drive and support process automation and scaling initiatives</li><li>Provide process technical support for clinical manufacturing, including deviation investigations, equipment troubleshooting, process failures</li><li>Provide expertise and training of the manufacturing staff on the T cell and/or plasmid manufacturing process and equipment</li><li>Work closely with the Supply chain, Quality Control, Validation, Engineering, Quality Assurance, and Regulatory Affairs functions internally to ensure the facility meets all appropriate standards and T cell/plasmid manufacturing process is performed per GMP requirements</li><li>Coordinate Manufacturing timelines and deliverables through the CMC team, Program Management, and other functions, as appropriate</li><li>Provide, write, and review relevant documentation for T cell/plasmid manufacturing operations and systems</li><li>Perform and support system testing, qualification, and validation</li><li>Position may require some travel</li></ul>Qualifications:<ul><li>BS/MS degree in engineering or life sciences with a strong technical background</li><li>8+ years of experience of related experience</li><li>5+ years of experience in Manufacturing or Development roles with more than 3+ years in a drug product development and manufacturing function at a biotechnology or pharmaceutical company</li><li>Knowledge and experience in leading a technology transfer</li><li>Hands-on experience with GLP, cGMP, and GCP is required</li><li>Experience with aseptic processing and cell therapy manufacturing is preferred</li><li>Experience working in manufacturing/process design is preferred</li><li>Experience in leading meetings, teams, and working directly with outside parties</li><li>Demonstrated management experience including employee development and leadership</li><li>Team player with the ability to influence others and serve as a change agent</li><li>Forward-thinking and creative with high ethical standards</li><li>Well organized and self-directed</li><li>Strong interpersonal skills with an ability to communicate to people at all levels of an organization</li></ul>PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.

Process Engineer

PACT Pharma is an exciting, well-funded clinical-stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient&rsquo;s individual tumor and engineering T cells to kill that specific tumor.&nbsp;If you desire a stimulating fast-paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.&nbsp; We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!&nbsp;We are in the San Francisco bay area, the heart of the world&rsquo;s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.&nbsp;We are currently recruiting for a Quality Assurance Director, Upstream Operations to report to the Vice President of Quality Assurance to continue advancing PACT&rsquo;s cutting edge engineered cell product. This will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives.&nbsp;What you will do: The ideal candidate is an experienced&nbsp;Quality Assurance leader&nbsp;with a track record of success in Upstream GMP&nbsp;operations with a background in Bioinformatics, Gene Editing, and Protein Science, understands clinical diagnostics, and autologous clinical processing. . The job incumbent will be responsible for&nbsp;building the Upstream Quality Assurance program, lead and mentor QA staff that&nbsp;support&nbsp;the following&nbsp;QA activities:&nbsp;&nbsp;<ul><li>Manage review and release of Upstream process patient screen data to support downstream clinical production.</li><li>Provide QA oversight and collaborate with Upstream teams to develop quality requirements and streamline the process and documentation to ensure compliance.</li><li>Partner with Upstream Operations to build Standard Operating Procedures for process, equipment and supporting programs.</li><li>Oversee training program and materials for Upstream clinical screening production staff.</li><li>Provide Quality insight into Upstream QMS processes; Change Control, Deviation/ CAPA generation, Risk Management</li><li>Review GMP quality metrics. Analyze data relating process controls, and continuous process improvement efforts. Coordinate with operations for the necessary quality adjustments.&nbsp;</li><li>Review relevant GMP documents for compliance to company SOPs, quality systems, and regulatory requirements.&nbsp;</li><li>Build effective Quality Assurance team to support Upstream operations</li><li>Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies.&nbsp;</li><li>Participate in or lead teams for special projects as assigned.&nbsp;</li><li>Develop and work with staff to implement quality process controls relating to all areas of operation, including the following systems: quality, facilities and equipment, materials management, production, packaging, and labeling.&nbsp;&nbsp;</li></ul>Minimal Qualifications:&nbsp;<ul><li> Bachelor&rsquo;s degree or higher in a relevant scientific discipline &ndash; Biology, BioChemistry, or Chemistry with minimum 10 years relevant industrial experience.</li><li> Prior management experience required.</li><li>Extensive experience with regulatory inspection and knowledge of their requirements. Ability to build strong working relationships with cross-functional departments.</li><li>The role demands a goal-driven approach and the ability to focus on time-sensitive objectives.</li><li>Demonstrated understanding through prior experience of GMP regulation and guidelines related to the conduct of cGMP.&nbsp;</li><li>Must have worked in clinical development as a Quality professional for a minimum of 5+ years and at least 8+ years total in a GMP environment.&nbsp;&nbsp;</li><li> Demonstrated strong problem solving and decision-making skill.</li><li> Strong teamwork, leadership, organization and communication skills.</li><li> Extensive cGMP quality system knowledge and experience is the required</li><li> Experience with Master Control eDMS and eQMS is desirable </li><li> Audit experience and/or certification is desirable.</li><li> Familiarity with molecular and protein&nbsp;</li></ul>PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.&nbsp;

Quality Assurance Director - Upstream Operations

PACT Pharma is an exciting, well-funded biotechnology company, advancing to clinical studies in 2019 with facilities and laboratories in South San Francisco, CA.&nbsp; PACT is developing personalized adoptive T cell therapies for the eradication of solid tumors.&nbsp; We are in the San Francisco bay area, in the heart of the world&rsquo;s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants.&nbsp;PACT is developing tumor-mutation-targeted T Cells tailored for each patient. Tumor mutation (neoE) targeting is programmed into the patient&rsquo;s own T cells to seek out &amp; kill the tumors. Using (non-viral) precision genome engineering, the neoE-targeted Tcell receptors (TCRs) replace the endogenous TCR of fresh CD8 and CD4 T cells collected from that same patient followed by minimal expansion in closed systems for re-infusion into the patient. These patient-specific neoTCR-P1 cells are formulated to immediately kill all neoantigen-expressing tumors, together with a deep reservoir of &lsquo;ready-to-go&rsquo; neoTCR-P1 cells for long term persistence and capable of rapid expansion to prevent future cancer recurrence.&nbsp;We are currently recruiting for Sr.&nbsp;Quality Assurance Engineer, reporting to the Director, Quality Assurance. This position will be based in South San Francisco.&nbsp;Responsibilities:The ideal candidate is an experienced QA Engineer with a track record of success in GMP environments and understands biologics and/or cell therapy processes (i.e. cell culture, expansion, fill/finish, aseptic environments, reagent/media control, contamination control). The job incumbent will be responsible for the following in support of QA activities:<ul><li>Draft and revise standard operating procedures (SOPs) to support PACT&rsquo;s Quality System.</li><li>Review validation protocols, executed validation studies, and validation summary reports as needed to support GMP manufacturing and laboratory systems.</li><li>Lead Quality initiatives for new GMP Aseptic product and raw material facility construction.&nbsp;</li><li>Partner and drive implementation for GMP new equipment program.&nbsp;</li><li>Review and approve investigations for manufacturing, quality control and other GMP systems. Initiate and manage improvements to programs based on trending or observations.</li><li>Review and approve change control as needed.</li><li>Review equipment maintenance and calibration certificates.</li><li>Provide training and guidance on Quality Assurance topics to foster a quality culture and quality mindset.</li><li>Perform compliance review of internal controls and procedures in PACT&rsquo;s Quality System and ensure alignment with current regulatory requirements.</li><li>Prepare Quality metrics to show the health of PACT&rsquo;s Quality System and make recommendations/improvements in policies and procedures.</li><li>Other functions as necessary for QA under management&rsquo;s discretion and in support of QA systems.</li></ul>Minimal Qualifications:<ul><li>Must have thorough working knowledge of personal computer systems and desktop office applications, including Word, Excel, and PowerPoint. Excellent verbal and written communication skills.</li><li>Ability to build strong working relationships with multiple departments.</li><li>Ideal candidate holds a bachelor&rsquo;s degree or higher in relevant biological sciences.</li><li>The role demands a highly goal-driven approach and the ability to focus on time-sensitive objectives.</li><li>Must have worked for 5+ years in industry with GMP quality assurance experience in a similar environment.&nbsp;</li></ul>PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.&nbsp;&nbsp;

Sr. Quality Assurance Validation Engineer

“I joined PACT to work with our impressive management team and innovative technologies to improve cancer therapies. It is the people that make this company exceptional and the mission to cure cancer that motivates me.”

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Director

"I joined PACT because of the science and the people!  PACT is a special place where people work hard because they are passionate about the science, committed to patients, value teamwork and push the boundaries to never accept the status quo. For those who thrive in a fast paced and innovative environment, PACT provides a rewarding opportunity to tackle challenging projects in a collaborative way."

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Susan.png

Vice President

“I joined PACT Pharma because I was energized by the people and the purpose of the organization and have been continuously impressed by the drive and ambition of the whole team to overcome any challenges. Being encouraged to be authentic with one another, and in all of our work, has really built a strong, unified team. This has been a unique and very rewarding experience for me.”

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Associate Director

“When I first interviewed at PACT, I remember being impressed by the collaborative and open nature of research within the company. It left quite the impression with me and ultimately guided me towards choosing a career at PACT. Since joining, I am continually grateful for the level of openness and collaboration between teams and departments that is crucial for pioneering scientific work."


Accelerating CurativeT Cell Therapiesfor Cancer

Tailored for Each and Every Person

Cellares Adds PACT Pharma to its Early Access Partnership Program

Who We Are

Mission & Vision

Our
Platform

Our
Programs

PACT Voices

Director

Technical Operations

Vice President

Program Management

Associate Director

Automation

Scientist

Tumor Immunology

Join Us

Process Development Scientist

Production Specialist

Accelerating CurativeT Cell Therapiesfor Cancer

Tailored for Each and Every Person

Cellares Adds PACT Pharma to its Early Access Partnership Program

Who We Are

Mission & Vision

OurPlatform

OurPrograms

PACT Voices

Director

Technical Operations

Vice President

Program Management

Associate Director

Automation

Scientist

Tumor Immunology

Join Us

Process Development Scientist

Production Specialist

Our
Platform

Our
Programs