Sr. QC Analyst

Legendcareers; Raritan (NJ); On-site; USD 83,711 - 109,870; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company match

Paid parental leave

Paid time off and holidays

Job summary

Legend Biotech is seeking a Sr. QC Analyst in Raritan, NJ, responsible for QC testing of CAR‑T products for clinical trials and commercial operations. The role demands compliance with cGMP regulations within a cleanroom environment.

The ideal candidate will hold a Bachelor’s degree in a relevant field and have at least one year of experience in Quality Control, preferably within the biological or pharmaceutical sectors. Strong communication skills and knowledge of CAR‑T QC methodologies are essential.

Qualifications

• 1+ years of relevant work experience in the biological/pharmaceutical industry.
• Experience in a Quality Control setting is preferred.
• Strong knowledge of CAR‑T QC test methods is an advantage.

Responsibilities

• Conduct QC testing for CAR‑T products in cGMP cleanroom.
• Ensure compliance with GMP regulations and SOPs.
• Perform peer reviews of laboratory data.

Skills

Communication skills

Aseptic technique

Knowledge of cGMP regulations

Team collaboration

Education

Bachelor’s Degree in Science or Engineering

Tools

LIMS

Biosafety cabinets

Job description

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

Role Overview

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.

Key Responsibilities

• 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.

Requirements

• 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.

Pay Range (Base Pay)

$83,711 – $109,870 USD

Benefits and Paid Time Off

Medical, dental, and vision insurance; 401(k) retirement plan with company match; eight (8) weeks of paid parental leave after three (3) months of employment; paid time off (vacation, personal, sick, floating holidays, and eleven (11) company holidays). Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance, supplemental plans (pet, critical illness, accident, hospital indemnity), voluntary commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs.

Please note: These benefits are offered exclusively to permanent full‑time employees. Contractors are not eligible for benefits through Legend Biotech.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company.

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