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’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’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 QC Associate who will help to continue advancing PACT’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. 

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.  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.

• 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
• 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.
• Identify and troubleshoot technical problems with equipment and analytical procedure.
• Draft and execute analytical procedure qualification/validation protocols and write reports.
• Design and conduct studies to optimize and improve the robustness of analytical procedures. 

Minimum Qualifications:

• The ideal candidate should hold a Bachelor’s degree in biological sciences, biotechnology, or related field of study with 4+ years’ experience, or hold a Master’s degree in Biotechnology or related field of study with 2+ years experience in a similar QC role.
• 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,.
• She/he is expected to maintain rigor and high quality of execution and documentation.
• The candidate should enjoy operating in an exceptionally dynamic and cooperative environment that is goal-driven to achieve time-sensitive objectives.
• She/he is highly dedicated to mentor team individuals, motivating team success, and contributing in a collegial manner to the entire company.
• 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. 

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.