CAR-T QC Technician (all levels)

Proclinical is seeking a CAR-T QC Technician (all levels) to work with a leading biotech company located in Somerville, NJ. The QC Analyst, CAR-T Manufacturing is a position responsible for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

*We are seeking all levels of experience from 1 year - 6+ years of industry experience. Multiple levels open depending on work experience*

Must be eligible to work or be a citizen in the US.

Job Responsibility:

• Be responsible for the completion of QC testing related to the manufacturing of autologous CAR-T 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.

Skills and Requirements:

• Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
• Minimum of 1 year's relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
• 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.
• 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.

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at (+1) 267-428-7770 or m.raletz@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-MR2