- 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.&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.

Corporate (South San Francisco)

Senior Research Associate – Process Development

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

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!&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.We are currently recruiting for an experienced Executive Assistant who will support Executive Committee members,but report to the Associate Director Human Resources and join a highly integrated Administrative team.&nbsp; PACT values the ability to highly collaborate and become part of an administrative team.&nbsp; This team helps coordinate employee events that support our newly minted Company values: Pioneering, Authentic, Collaborative, Trustworthy.Responsibilities:<ul><li>Proactively provide administrative support to members of PACT&rsquo;s Executive and/or Sr. Management teams</li><li>Coordinate management&rsquo;s communications, including taking calls, responding to emails and interfacing with guests</li><li>Schedule and coordinate meetings, appointments and corporate visits; manage travel and itineraries and assist with expense reporting</li><li>Manage various aspects of Board interactions, correspondence, as well as meeting activity</li><li>Prepare internal and external corporate documents for team members and industry partners</li><li>Own and manage projects of intermediate-complex scope that require good judgment, strong analytical skills, and effective communication</li><li>Manage daily operations of the office with other Executive Assistants including maintaining and stocking office supplies, scanning documents to appropriate departments, distributing mail, stocking snacks and refreshments and other general office needs.</li><li>Assist with arrangements for corporate events that take place both at and outside of the workplace; such events include off-sites and employee appreciation events</li><li>Complete various ad hoc projects as assigned</li><li>Assist in the development of materials and meeting documents</li><li>Coordination of conference/meeting room set up, catering, and making logistical arrangements&nbsp;</li></ul>Minimum Qualifications:<ul><li>8+ years of experience as an Executive Assistant reporting directly to a C level executive</li><li>Must be a team player and provide back up support to other admins and support staff as requested</li><li>Strong multi-tasking skills and ability/desire to wear multiple hats</li><li>Must be able to effectively manage and prioritize workload from multiple client groups</li><li>Must possess strong organizational, project management and problem-solving skills with impeccable attention to detail and multi-tasking abilities.</li><li>Bachelor&rsquo;s degree or equivalent required.</li><li>Pharmaceutical or Biotech industry background strongly preferred.</li><li>Advanced Microsoft Office skills, with an ability to become familiar with company-specific programs and software.</li><li>Ability to work in a fast-paced collaborative start up environment as a team player and pitch in where and when ever needed.</li><li>Ability to uphold a strong work ethic and good attitude under pressure.</li><li>The ideal candidate must uphold a strict level of confidentiality, develop and sustain a level of professionalism among staff and visitors and have exceptional interpersonal skills coupled with a friendly and professional demeanor.</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;

Executive Assistant

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.

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. In principle, this technology can be used to treat any cancer type.&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 about eradicating cancer, come join our team!&nbsp;We are currently recruiting for a Shipping and Receiving Associate who will report to the Head of Supply Chain 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:Perform general facilities duties which primarily include, but are not limited to:<ul><li>Receiving packages, entering into Shipping &amp; Receiving tracking database, and delivering to employees and/or GMP storage areas</li><li>Processing pre-packaged outgoing shipments, ensuring accuracy, completeness, promptness, accountability, and condition of shipments meet established standards</li><li>Performs inventory control: cycle counts, material stocking, and scrapping</li><li>Manages material expiry, allocation, kitting and maintains material condition requirements</li><li>Maintains timing according to the production schedule to ensure on-time logistics</li><li>Works in a team-based, cross-functional environment to complete warehousing tasks required by shift schedule</li><li>Acting as an on-site Point-of-Contact for end-users regarding Shipping &amp; Receiving support</li><li>Escorting delivery personnel and special equipment when necessary</li><li>Safely utilizing pallet jacks and delivery carts to transport materials to GMP storage areas</li><li>Following site-specific SOPs and work procedures</li><li>Ensuring work areas are clean, organized, and safe</li><li>This position has no direct reports</li></ul>Minimal Qualifications:<ul><li>Knowledge of cGMP/FDA regulated industry</li><li>Basic mathematical skills</li><li>General understanding of cGMPs</li><li>Proficient in MS Office applications</li><li>Inventory control and/or management</li><li>Background to include an understanding of biology, chemistry, medical or clinical practices is a plus</li><li>High School Diploma/G.E.D.</li><li>Customer Service skills experience</li><li>Familiarity with the laboratory environment and/or Shipping &amp; Receiving environment a plus but not required</li><li>Ability to safely lift items, heavy packages, and carry short distances</li><li>Proficient with the Microsoft ecosystem (Windows, Office, Office 365, etc.)</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.

Material Handler  (Temporary)

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.

Senior Quality Control Associate II

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 temporary Quality Assurance Document Specialist who will report to the Manager, Quality Assurance Operation. The ideal candidate is an experienced Documents Specialist with a track record of success in the life science industry. The job incumbent will be responsible for updating documentation into approval workflow, filing/ scanning documents, and document inventory/ archival.&nbsp;Responsibilities:<ul><li>Coordinate and process documentation within Master Control, electronic Document Management System (MC-eQMS) to meet cGMP and ISO9001 requirements.</li><li>Scanning, filing, maintenance, and retrieving of all types of documents and quality records.</li><li>Print controlled cGMP logbook, log sheet, to support upstream &amp; downstream manufacturing process.</li><li>Support cross-functional teams with hard copy filing and retrieving documents from the outside storage vendors.</li><li>Assign and monitor document numbers, part numbers, &amp; update logs and databases.</li><li>Receive, review, control, and track documents per relevant process and procedures.&nbsp;</li></ul>Qualifications:<ul><li>Bachelor&rsquo;s degree with 3+ years of quality assurance or equivalent experience is preferred</li><li>Experience with Master Control Electronic Document Management System is desirable</li><li>Knowledge of documentation control requirements for the pharmaceutical industries.</li><li>Solid knowledge of personal computer systems and desktop office applications, including Word, Excel, and PowerPoint</li><li>Strong verbal and written communication skills</li><li>Ability to build strong working relationships with multiple departments</li><li>Highly goal-driven approach and the ability to focus on time-sensitive objectives</li><li>Must be able to work independently with minimum supervision</li><li>Strong organizational skills, with the ability to successfully manage multiple priorities&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 based on race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.&nbsp;

QA Document Specialist Temp

You are invited to our virtual PACT Pharma Open House!&nbsp; &nbsp;This event includes:&nbsp;&nbsp;<ul><li>An introduction to our open positions from our recruiters, how to apply, and what PACT Pharma looks for</li><li>You'll hear from some of our Scientists &amp; RA's about what it's like to work here, info about our technology, and what they love about PACT Pharma</li><li>Our CEO, Alex Franzusoff, will bring you on a journey of our science and process.</li><li>We will also answer your questions!</li></ul>Please click on the link below to RSVP and submit any questions&nbsp;you want answered during our Open House in the&nbsp;RSVP "comment" box!&nbsp; &nbsp;If you forget, don't worry, we will have a way for you to ask during the Open House with any of our remaining time.&nbsp; &nbsp;We will start at 4:30pm Thursday March 4th.We look forward to seeing you there!PACT Talent Acquisition&nbsp;Team <a href="http://evite.me/J1DEkjN7pa">http://evite.me/J1DEkjN7pa</a>

Open House

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 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: The ideal candidate is an experienced&nbsp;Quality Assurance leader&nbsp;with a track record of success in ATMP/ GMP&nbsp;operations with experience in bioinformatics, gene editing, and protein science which makes up PACTs clinical screening process. An understanding of clinical diagnostics, clinical laboratory screening and autologous clinical processing is desired. The job incumbent will help to build the 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 patient screen data to support autologous Cell Therapy clinical production.</li><li>Provide QA oversight and collaborate with operations to develop quality requirements and streamline the process and documentation to ensure compliance.</li><li>Partner with operations to build Standard Operating Procedures for process, equipment and supporting programs.</li><li>Oversee training program and materials for clinical screening production staff.</li><li>Provide Quality insight into 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 an effective Quality Assurance team to support QA 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; Bioinformatics, Biology, Biochemistry, or Chemistry with minimum of 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 ATMP/ GMP regulation and guidelines related to the conduct of early phase clinical programs.&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 skills.</li><li> Strong teamwork, leadership, organization, and communication skills.</li><li> Extensive cGMP quality system knowledge and experience is 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;clinical screening programs</li><li>CLIA experience desired</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 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/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; Location:&nbsp; South San Francisco, CAWhat 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/Clinical Research Associate

<div></div><div>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. 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 about eradicating cancer, come join our team!We are currently recruiting for&nbsp;a Quality Assurance Validation Engineer &ndash; Informatics / Equipment Automation professional, reporting to the Quality Assurance Senior Validation Engineer. This position will be based in&nbsp;South San Francisco.&nbsp;The ideal candidate is an experienced Quality Assurance Validation Engineer with experience in working with COTS and custom programs in early phase clinical environments to provide compliance oversight in support of software and infrastructure designed to support automated processing.Responsibilities:<ul><li>Act as a representative for custom internal Automation equipment projects</li><li>Support in building quality management systems necessary for compliant software development, validation, and verification as described in current GAMP guidance</li><li>Review requirements, specifications, technical design documents, and summary reports to provide timely feedback.</li><li>Work with&nbsp;PACT&nbsp;team on regulatory,&nbsp;quality compliance strategies and execution&nbsp;in support of&nbsp;Upstream operations&nbsp;automation.</li><li>Review and update test protocols&nbsp;according to GAMP / 21 CFR Part 11 standard.</li><li>Participate in automation equipment qualification and provide quality guidance for developing User Requirement and Risk Assessment documentation and drafts of IQ/OQ/PQ Protocols/Reports for Equipment Lifecycle Management.</li><li>Help to establish quality processes within the automation team, including risk assessment, test strategy and plan, execution of test cases, tracing requirements, and other standard operating procedures and work instructions.</li><li>Works with stakeholders to assist with change controls and computer systems validation documents including Impact Assessments, Action Plans, and Risk Assessments, Protocols, and Reports.</li><li>Support software vendor qualification activities including risk assessments and due diligence audits.</li><li>Provide support during inspections and audits.&nbsp;</li></ul>Qualifications:<ul><li>B.S. degree in computer sciences or related field with 5+ years of quality assurance in biotech or pharma industry.</li><li>Experience in Quality oversight of GMP computer systems and Bio-Tech automation field and understanding of quality risk management principles.</li><li>Experience in GAMP5, 21 CFR Part 11, Annex 11.</li><li>Solid Knowledge of IQ/OQ/PQ.</li><li>Experience in GXP Environment.</li><li>Experience with implementation and continuous improvement of Quality Systems supporting CSV.</li><li>Experience with vendor audits.</li><li>Experience with implementation and validation of computer systems to support a new facility design, commissioning, qualification.</li><li>Ability to communicate well across different disciplines and experience levels.</li><li>Experience supporting regulatory inspections.</li><li>Experience using risk management tools (FMEA, etc.).</li><li>Knowledgeable in Software Development Lifecycle (SDLC).&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;</div>

Quality Assurance Validation 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 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&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 a&nbsp;Scientist I,&nbsp;Protein Sciences&nbsp;who will report to the Associate Director of&nbsp;Laboratory Operations,&nbsp;Protein Sciences 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 individual will be responsible for the execution of high-throughput cloning, protein expression and purification in the critical path for the discovery of&nbsp;neoEpitopes&nbsp;and corresponding cognate TCRs. The position involves a considerable amount of bench work in a GMP-like environment&nbsp;executing&nbsp;protocols and&nbsp;authoring&nbsp;SOPs&nbsp;to support our clinical trial. The ideal candidate should have keen attention to details, be highly organized and should enjoy operating in an exceptionally dynamic and collaborative environment.&nbsp; Responsibilities:&nbsp;<ul><li>Work with the&nbsp;HTP protein production&nbsp;operations team&nbsp;to streamline the workflow and optimize the pipeline to improve efficiency in the operations process</li><li>Lead&nbsp;2-3 highly competent RA&rsquo;s and assign work on a daily and weekly basis</li><li>Serve as the technical lead on the small-scale&nbsp;protein production&nbsp;operations pipeline and provide scientific guidance to the junior staff</li><li>Implement&nbsp;solutions to&nbsp;operations pipeline bottlenecks</li><li>Resolve&nbsp;quality issues with production pipeline as and when they arise</li><li>Coordinate and collaborate&nbsp;with other scientists in the team to reduce cycle-time and improve efficiency</li><li> Track and prioritize activities within the small-scale&nbsp;protein production&nbsp;sub-group</li></ul> Qualifications:&nbsp;<ul><li>Masters&nbsp;with&nbsp;5+&nbsp;years of experience in Protein Biochemistry, Molecular Biology or related disciplines</li><li>Experience with HTP molecular cloning, protein expression&nbsp;&amp;&nbsp;analysis&nbsp;is required</li><li>Prior experience with mammalian cell culture and with recombinant protein expression&nbsp;is essential</li><li>Acute attention to details, well-organized, diligent with documentation</li><li>Highly goal-driven&nbsp;with&nbsp;the ability to handle delicate experiments in a timely manner</li><li>Able to operate in a collaborative environment and communicate clearly and concisely, both verbally and in the form of written reports</li><li> Experience working with automated platforms</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;&nbsp;

Scientist I

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

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

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

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’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.  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’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 searching for an Associate Director of Process Development who will report to the Executive Director of Process Development within our TCR discovery and validation group. The ideal candidate should have extensive experience in receiving research protocols, developing and qualifying robust processes, and deploying them into a production environment. The position will provide cross-functional leadership to Scientists and Research Associates supporting the development of patient T cell receptor (TCR) screening and verification processes for PACT’s ongoing clinical trials while rapidly operationalizing the pipeline in preparation for future commercialization.   This will be a unique opportunity to improve and operationalize PACT’s cutting-edge personalized TCR discovery process and see our clinical pipeline through to commercial launch and beyond while having a direct impact on patient lives. Responsibilities: <ul><li>Provide scientific expertise to the entire process development team in the areas of NGS and single-cell multi-omics </li><li>Lead and mentor on process development best practices </li><li>Develop, qualify, and implement processes that improve key operational metrics including robustness, reliability, turn-around-time, quality, and cost </li><li>Apply Quality-by-Design principles to define robust, integrated control strategies </li><li>Solve scale-up/scale-out challenges </li><li>Work in collaboration with R&amp;D, software engineering, automation engineering, QA, and production to develop and deploy high-throughput laboratory automation and software solutions with thorough process controls </li><li>Lead troubleshooting efforts using recognized tools to ensure high production pipeline availability and continuous quality </li><li>Support regulatory activities including authoring and review of study reports and CMC documentation for regulatory filings </li></ul>Qualifications:   <ul><li>Ph.D. degree in cell or molecular biology, immunology, bioengineering, or other relevant biological sciences or engineering disciplines </li><li>8+ years of industry experience carrying out process development and technical transfer </li><li>5+ years of industry experience developing and operationalizing NGS-based workflows </li><li>Experience carrying out process characterization to identify and control sources of variability using designed experiments and statistical tools </li><li>Experience in systematic troubleshooting and root case analysis in a production environment using recognized tools </li><li>Experience developing and characterizing the performance of analytical and functional test methods to ensure quality </li><li>Experience designing and executing validation plans for equipment, processes, and test methods </li><li>Innovative, motivated, and independent leader with a willingness to spend significant hands-on time coaching and mentoring team members </li><li>Experience operating within a formal quality management system such as CLIA, ISO 13485, or CFR 211 </li><li>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.

Associate Director, Process Development

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. In principle, this technology can be used to treat any cancer type.&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&nbsp;Director, Clinical Data Management who will report to Vice President 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. The Director, Clinical Data Management is accountable for ensuring study launch, conduct, and closeout are performed according to PACT's quality standards, Standard Operating Procedures (SOPs), and International Conference on Harmonization (ICH) Good Clinical Practices (GCPs) to fulfill all federal and local regulations. Duties include serving as the primary data management liaison with vendors and senior management.&nbsp;Responsibilities:<ul><li>Serve as the Clinical Data Manager for multiple clinical trials</li><li>Manage vendors that have been contracted to handle PACT's clinical data (e.g., EDC vendors, CROs, Labs, etc.) and ensure the data are complete, accurate, and delivered within the timelines agreed to</li><li>Lead the design of the eCRFs and ensure that they support the clinical study objectives</li><li>Ensure complete and accurate CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, and data management plans</li><li>Ensure data is reviewed on an on-going basis, including individual subject data within the EDC, datasets, Tables, Figures, and Listings (TFL), etc. that are generated for CSRs, DSURs, IBs, and other business needs</li><li>Develop a data cleaning plan and ensuring all reviews have been completed and all documentation has been finalized and approved for final database locks in a regulatory-compliant manner</li><li>Act as team SME for key systems and processes, and process enhancement efforts</li><li>Ensure compliance with applicable Corporate Policies and procedures</li><li>Manage and communicate progress and expectations around DM Operations processes and the Clinical Study</li><li>Maintain accountability for supporting and utilizing policies and procedures&nbsp;</li></ul>Qualifications:<ul><li>Bachelor's degree in health or science, or equivalent practical experience or an advanced degree is a plus with 10+ years of direct data management experience (Oncology experience highly desirable)</li><li>Must demonstrate expertise in designing systems and creating system specifications. Expertise in using analytics tools preferred</li><li>Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices</li><li>Experience developing and maintaining CDM SOPs</li><li>Electronic Data Capture (EDC) experience with Medidata Rave required</li><li>Demonstrated effective communication skills</li><li>Must demonstrate expertise in influencing teams during the design, conduct, and completion of trials</li><li>Must have experience leading matrixed teams&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;

Director, Clinical Data Management

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.

“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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Rebecca.jpg

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

Senior Research Associate – Process Development

Sr. Quality Assurance Validation Engineer

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

Senior Research Associate – Process Development

Sr. Quality Assurance Validation Engineer

Our
Platform

Our
Programs