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QC Microbiologist

Job Attributes

Job Id:

30282

Job Category:

Biotechnology

Job Location:

Raritan, NJ  08869

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions

JOB DESCRIPTION

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 kkpallone@pipercompanies.com


Keywords: 

Quality Control, QC, EM, Environmental Monitoring, CAPA, Pharmaceutical, Gowning, PPE, 21 CFR, SOP, Recent Graduate, Biochemistry, Microbiology, Biology, Documentation, Trend Analysis

 

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New Search

Job Id:

30282

Job Category:

Biotechnology

Job Location:

Raritan, NJ  08869

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions