Sr. QC Analyst

Role Overview:
- Exempt position performing QC testing related to manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

Key Responsibilities:
- Complete QC testing for autologous CAR-T products (clinical trials and commercial) in a controlled cGMP cleanroom.
- Ensure testing complies with applicable procedures, standards, and GMP regulations.
- Conduct analytical testing of raw material/utility, in-process, or final product samples.
- Perform peer review/approval of laboratory data.
- Use LIMS for execution and documentation of testing.
- Create, review, and approve QC documents, SOPs, and work instructions.
- Follow safety policies, quality systems, and cGMP requirements.
- Collaborate with Quality Assurance, Manufacturing Operations, and Analytical/Process Development.
- Routinely handle biological materials and hazardous chemicals.

Requirements:
- Bachelor’s degree in Science/Engineering or equivalent technical discipline.
- Minimum 1 year relevant experience (biological/pharmaceutical industry preferred).
- Knowledge of Good Tissue Practices (required).

Preferred/Strongly Preferred Skills:
- QC experience.
- Aseptic processing in biosafety cabinets.
- cGMP regulations and FDA/EU guidance for cell-based products.
- CAR-T QC test methods and related equipment.

Additional Requirements:
- Excellent written and oral communication.
- Ability to work shift schedule (including weekends/evenings) and unplanned overtime with little notice.
- Comfort speaking/interacting with regulatory inspectors.
- Occasional travel to partner sites in NJ/PA and up to 5% domestic/international travel as needed.

Benefits:
- Benefits are offered exclusively to permanent full-time employees (contractors not eligible).