Senior QA Associate, Microbiology
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 and work with intelligent people who are making an impact on cancer, you will want to join the PACT Pharma team. We are a diverse work family with a dynamic and earnest culture. We are an innovative and collaborative workforce working towards one main goal - eradicating cancer!
We are located in the San Francisco bay area. 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 QC Associate III / Senior Associate for the QC Microbiology group, reporting to the Senior Manager of QC Microbiology and continue advancing PACT Pharma’s cutting-edge engineered cell product. This will be a unique opportunity to see your contributions to PACT Pharma’s personalized process rapidly translate into the clinic and impact patient lives.
What You Will Do:
- Collect environmental, personnel, and utility samples of cleanroom manufacturing facilities following written sampling plans
- Perform clinical product in-process and lot release testing
- Assess new rapid microbiology methods and analytical technology for suitability to support the manufacture and assess the quality of cell therapy products.
- Lead and perform microbiological method transfer and validation (e.g. rapid sterility, endotoxin, mycoplasma)
- Design and support qualification of cleanroom facilities and clean utilities
- Review data obtained for compliance to specifications and reports abnormalities and applies critical thought to solving problems of complex scope
- Lead laboratory investigations and support deviation investigations for cGMP clinical manufacturing and supporting QC equipment
- Be a liaison (SME) across functions to ensure adherence to microbial contamination control strategies and ensure product quality
- General QC Microbiology lab support including housekeeping, equipment maintenance, and supplies inventory; knowledge of Laboratory 5S principles, preferred.
- Candidate must apply knowledge of cGMP/GLP, and adhere to company safety procedures and guidelines
- Document sampling and testing in accordance with Good Documentation Practices
- Bachelor’s degree in relevant biological sciences (Microbiology degree preferred)
- Minimum of 8 years of experience of QC related experience in the Pharmaceutical and/or biologics industry
- Pharmaceutical microbiology knowledge and hands-on experiences in quality control testing, such as surface and air monitoring, bioburden testing, endotoxin testing, sterility testing, growth promotion, and Gram stain
- Prior experience in environmental monitoring and quality control microbiology laboratory testing for a GMP manufacturing facility
- Strong analytical and problem-solving skills
- Proficient aseptic technique and preferred experience in gowning procedures
- Well organized and able to shift priorities effectively
- Good communication skills both verbally and written
- Ability to work independently as well as within a team, demonstrate initiative and accountability, and strong attention to detail
- The candidate should enjoy operating in an exceptionally dynamic and cooperative environment
- They must be able to communicate clearly and concisely, both verbally and in the form of written reports, laboratory notebooks, and batch records.
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.