QC Analyst I (Biotech)

TL;DR

QC Analyst I (Biotech): Performing quality control testing for cell therapy manufacturing in a cGMP environment with an accent on aseptic techniques and analytical testing of clinical and commercial products. Focus on ensuring compliance with regulatory standards, managing laboratory documentation via LIMS, and collaborating with cross-functional teams to support life-saving immunotherapy production.

Location: Must be based in Raritan, NJ (Onsite)

Salary: $68,045 - $95,540 USD

Company

A global biotechnology company dedicated to developing advanced cell therapies for life-threatening diseases, including CAR-T and TCR-T immunotherapies.

What you will do

• Perform QC testing for autologous CAR-T products in a cGMP cleanroom environment.
• Conduct analytical testing of raw materials, in-process samples, and final products.
• Utilize LIMS for documentation and execution of laboratory testing.
• Perform peer review and approval of laboratory data to ensure accuracy.
• Create and maintain QC documents, SOPs, and work instructions.
• Collaborate with Quality Assurance and Manufacturing teams to maintain quality standards.

Requirements

• Bachelor’s Degree in Science, Engineering, or equivalent technical discipline required.
• Minimum 1 year of relevant work experience in a biological or pharmaceutical industry.
• Must be able to accommodate a shift schedule including routine weekend and evening work.
• Must be able to accommodate unplanned overtime on little to no prior notice.
• Knowledge of cGMP regulations and Good Tissue Practices.
• Excellent written and oral communication skills.

Nice to have

• Experience in a Quality Control setting.
• Experience processing samples in biosafety cabinets using aseptic technique.
• Knowledge of CAR-T QC test methods and related equipment.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan with company match vesting on day one.
• Eight weeks of paid parental leave after three months of employment.
• Generous paid time off policy including vacation, sick, and personal time.
• Access to well-being initiatives, family planning resources, and peer-to-peer recognition programs.