Sr. QC Analyst (Biotech)

TL;DR

Sr. QC Analyst (Biotech): Performing quality control testing for cell therapy manufacturing in a cGMP environment with an accent on aseptic techniques and analytical testing of raw materials and final products. Focus on ensuring compliance with FDA/EU regulations, managing laboratory data via LIMS, and collaborating with cross-functional teams to support clinical and commercial operations.

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

Salary: $83,711 - $109,870 USD

Company

hirify.global is a global biotechnology company developing advanced cell therapies, including CAR-T and NK cell-based immunotherapies, to treat life-threatening diseases.

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.
• Review and approve laboratory data and maintain documentation in LIMS.
• Create and update QC documents, SOPs, and work instructions.
• Collaborate with Quality Assurance, Manufacturing, and Analytical Development teams.
• Ensure all activities comply with safety policies and cGMP regulations.

Requirements

• Bachelor’s Degree in Science, Engineering, or equivalent technical discipline.
• Minimum 1 year of relevant work experience in a biological or pharmaceutical industry.
• Knowledge of cGMP regulations and FDA/EU guidance for cell-based products.
• Ability to work flexible shifts, including evenings, weekends, and unplanned overtime.
• Experience with aseptic technique in biosafety cabinets.
• Knowledge of Good Tissue Practices.

Nice to have

• Experience in a Quality Control setting.
• 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.
• 8 weeks of paid parental leave after 3 months of employment.
• Generous paid time off policy including vacation, sick, and 11 company holidays.
• Supportive culture with well-being initiatives and family planning resources.