Piper Companies is looking for a Quality Control Microbiologist, CAR-T Manufacturing to join a biologics manufacturer in Raritan, NJ.
The QC Microbiology Specialist, CAR-T Manufacturing is a position with responsibilities for performing routine Environmental Monitoring sampling of the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
Responsibilities for the Quality Control Microbiologist, CAR-T Manufacturing include:
- Responsible for performing routine EM sampling, including viable/non-viable air and surface sampling, related to the manufacturing of autologous CAR-T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment.
- Work with Process Development team, Quality and Operations organization to successfully transfer process to cGMP facility to manufacture products.
- Create, review and approve relevant QC documents, SOP’s and WI’s.
- Ensure microbiological control strategy is consistent with cGMP requirements.
- Participate in training and delivery of Operations aseptic technique and microbiology awareness training program.
- Maintain, re-evaluate and communicate key critical inputs to site environmental monitoring program.
- Perform peer review/approval of laboratory data.
- Utilize electronic systems (LIMS) for execution and documentation of testing.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Qualifications for the Quality Control Microbiologist, CAR-T Manufacturing include:
- B.S in Biochemistry, Microbiology, Chemistry or related field
- 2+ years experience within biologics or pharma
- Experience working within a sterile environment
- Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required
- CAR-T test methods and equipment is highly preferred
Compensation for the Quality Control Microbiologist, CAR-T Manufacturing include:
- $55,000-$75,000, depending upon experience
- Full benefits
Please send all qualified resumes to Karen Pallone at firstname.lastname@example.org
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