QC Analyst I/II

About the role

Legend Biotech is a global biotechnology company advancing next-generation cell therapies, including CAR-T, TCR-T, NK cell-based therapies, and other platforms for serious diseases. Through a collaboration with Johnson & Johnson, the company co-develops and commercializes CARVYKTI® (cilta-cel) for multiple myeloma. The QC Analyst will support the manufacturing of autologous CAR-T products in a controlled cGMP cleanroom environment at the Raritan, NJ site.

Responsibilities

• Perform QC testing for autologous CAR-T products in clinical trials and commercial operations within a controlled cGMP cleanroom environment.
• Ensure testing complies with applicable procedures, standards, and GMP regulations.
• Conduct analytical testing of raw material/utility, in-process, and final product samples.
• 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 work instructions.
• Work collaboratively with Quality Assurance, Manufacturing Operations, and Analytical/Process Development teams.
• Handle biological materials and hazardous chemicals in accordance with safety policies and cGMP requirements.

Requirements

• Bachelor’s degree in Science, Engineering, or equivalent technical discipline.
• Minimum of 1 year of relevant work experience, preferably in 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 cell-based product manufacturing 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.
• Ability to accommodate shift schedules, including routine weekend and evening work, and unplanned overtime with little notice.
• Highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Comfortable interacting with regulatory inspectors.
• Occasional travel to partner sites in NJ or PA (up to 5% domestic or international travel) may be required.

Qualifications

• Takes responsibility for results and deliverables; sets and achieves goals aligned with organizational priorities.
• Takes initiative; willing to take unpopular positions/actions when necessary; acts courageously and assertively.
• Works effectively amid ambiguity, shifting priorities, and rapid change; maintains a positive outlook in difficult situations.
• Identifies and focuses on high-value activities; makes informed decisions quickly.
• Results-oriented; defines goals, metrics, and actionable plans; manages work to deliver outcomes with a sense of urgency.
• Considers resources, alternatives, constraints, and desired outcomes to make effective decisions.
• Employs good project management principles to align time, resources, and budgets.
• Appreciates diverse perspectives; actively inclusive of others’ input; treats others with respect.
• Articulates ideas clearly and succinctly in various settings; tailors messages for desired impact.
• Leverages credibility and interpersonal skills to help others make better decisions and positively influence outcomes; builds and maintains effective internal and external relationships.
• Employs a global mindset in decision-making; over-communicates to foster organizational transparency, trust, and alignment.
• Takes initiative; shares knowledge; builds skills; promotes new ideas; embraces change.
• Generates innovative solutions by challenging the status quo and conventional thinking.

Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match vested fully on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid time off including vacation, personal time, sick time, floating holidays, and eleven company holidays.
• Voluntary benefits: flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
• Voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.

Pay

The base pay range for this role is $68,045 USD – $89,308 USD. Actual compensation may vary based on experience, skills, qualifications, and geographic location. Performance-based bonus and/or equity may be available to eligible employees.