QC Analyst

The QC Analyst, CAR-T Manufacturing is an exempt level position with responsibilities for performing 
QC testing related to the manufacturing of cell therapy products for clinical trials and commercial 
operations in a controlled GMP environment. 

Major Responsibilities:

• Responsible for the completion of QC testing related to the manufacturing of autologous CART products for clinical trials and commercial operation in a controlled cGMP cleanroom 
  environment.
• Ensure testing is completed in compliance with all applicable procedures, standards and GMP 
  regulations.
• Work with Process Development team, Quality and Operations organization to successfully 
  transfer process/analytical testing to cGMP facility to manufacture products.
• Conduct analytical testing of raw material/utility, in-process, or final product samples 
  submitted to the QC laboratories.
• Perform peer review/approval of laboratory data.
• Utilize electronic systems (LIMS) for execution and documentation of testing.
• Create, review and approve relevant QC documents, SOP’s and WI’s.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP 
  requirements.
• Other duties will be assigned, as necessary

Qualification

Education:

A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical 
discipline is required or relevant years of experience within the pharmaceutical 
industry.

Experience:

A minimum of 1-2 years relevant work experience is required. It is preferable that 
the candidate have experience working in an aseptic manufacturing facility, 
preferably in quality assurance, manufacturing compliance, clinical quality, or cell 
therapy. 

Capabilities, Knowledge, and skills:

• Experience in a Quality Control setting is preferred.
• Experience with aseptic processing in ISO 5 clean room and biosafety 
  cabinets is required.
• Knowledge of cGMP regulations and FDA/EU guidance related to 
  manufacturing of cell-based products is required.
• Knowledge of Good Tissue Practices is required.
• Detailed knowledge of CAR-T QC test methods and related equipment is 
  preferred
• Excellent written and oral communication skill are required
• Candidates must be able to accommodate shift schedule. Shifts include 
  routine weekend and evening work as required by the manufacturing 
  process.
• Candidates must be able to accommodate unplanned overtime (including 
  nights and weekends) on little to no prior notice.
• The candidate must be highly organized and capable of working in a team 
  environment with a positive attitude under some supervision.
• Comfortable with speaking and interacting with inspectors.
• This position may require occasional travel to partner sites in NJ or PA as 
  business demands.
• This position may require up to 10% domestic or international travel as 
  business demands. 

Language(s):

English

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