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 direct contribution to bringing novel personalized cell therapies to the clinic and impact patient lives.
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. As member of the QC team, the Sr. QC Associate contributes to all aspects of the day to day laboratory operations.
- 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
- 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.
- Identify and troubleshoot technical problems with equipment and analytical procedure.
- Draft and execute analytical procedure qualification/validation protocols and write deviations, change control or OOS investigation reports.
- Design and conduct studies to optimize and improve robustness of analytical procedures.
- The ideal candidate should hold a Bachelor’s degree in biological sciences, biotechnology or related field of study with 5+ years’ experience, or hold a Master’s degree Biotechnology or related field of study with 4+ year experience in a QC laboratory.
- Hands on experience with PCR, Agarose gel electrophoresis, immunoassays, and other molecular biology methodologies in a GMP/GLP laboratory, including qualification/validation.
- Experience performing stability, in-process and release product testing in a GxP labortory
- 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.
- She/he is expected to maintain rigor and high quality of execution and documentation.
- She/he must be able to work independently on projects and write detailed reports, perform data trending, work with LIMS system.
- Candidate should enjoy operating in an exceptionally dynamic and cooperative environment that is goal-driven to achieve time-sensitive objectives.
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.