Sr. QC Analyst

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell (CAR‑T), T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our R&D sites around the world, we pursue discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of Johnson & Johnson’s pharmaceutical companies, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). This partnership combines the strengths and expertise of both companies to advance an immunotherapy for multiple myeloma.

Sr. QC Analyst – Quality team, Raritan, NJ

Shift: 3rd shift Wed‑Sat

The Sr. QC Analyst is an exempt level position responsible for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled cGMP environment.

• Complete QC testing for autologous CAR‑T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment.
• Ensure testing complies with all applicable procedures, standards and GMP regulations.
• Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
• Perform peer review and approval of laboratory data.
• Utilize electronic systems (LIMS) for execution and documentation of testing.
• Create, review and approve relevant QC documents, SOPs and WIs.
• Perform tasks in compliance with safety policies, quality systems and cGMP requirements.
• Work collaboratively with Quality Assurance, Manufacturing Operations and Analytical/Process Development.
• Handle biological materials and hazardous chemicals with routine exposure.

• Bachelor’s Degree in Science, Engineering or equivalent technical discipline.
• Minimum of 1 year relevant work experience, preferably within a biological and/or pharmaceutical industry.
• Experience in a Quality Control setting is preferred.
• Experience processing samples in biosafety cabinets using aseptic technique is strongly preferred.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell‑based products is strongly preferred.
• Knowledge of Good Tissue Practices is required.
• Knowledge of CAR‑T QC test methods and related equipment is preferred.
• Excellent written and oral communication skills.
• Must accommodate shift schedule, including routine weekend and evening work and unplanned overtime.
• Highly organized and capable of working in a team environment with a positive attitude.
• Comfortable speaking and interacting with regulatory inspectors.
• Occasional domestic travel to partner sites in NJ or PA; up to 5% domestic or international travel.
• Responsible for results and deliverables; self‑directed goal setting.
• Initiative and willingness to take unpopular positions or actions when necessary.
• Effective decision‑making under ambiguity, shifting priorities, and rapid change.
• Identifies high‑value activities and makes informed decisions quickly.
• Results oriented; defines goals, metrics and actionable plans.
• Considers resources, alternatives, constraints and desired outcomes in decisions.
• Employs good project management principles to align time, resources and budgets.
• Embraces diversity, inclusivity and respectful collaboration.
• Articulates ideas clearly and succinctly in various settings.
• Leverages personal credibility and interpersonal skills to drive better decisions and outcomes.
• Employs a global mindset and values over‑communication for transparency and alignment.
• Takes initiative, shares knowledge, builds skills, promotes new ideas and embraces change.
• Generates new solutions by challenging status quo and conventional thinking.

$83,711 – $109,870 USD

Medical, dental, and vision insurance; 401(k) retirement plan with company match; eight (8) weeks of paid parental leave after three (3) months of…