QC Analyst I/II

Legend Biotech USA; Raritan (NJ); On-site; USD 65,000 - 90,000; Full time

Job summary

Legend Biotech in Raritan, NJ is seeking a QC Analyst to join the Quality Operations team. The exempt role performs QC testing for autologous CAR-T product manufacturing in a controlled cGMP environment, supporting clinical trials and commercial operations.

You will execute testing, review data, use LIMS, prepare and approve QC documents, and collaborate with QA, Manufacturing, and Analytical Development. This role involves handling biological materials, safety protocols, and occasional travel

Qualifications

• Bachelor's degree in science, engineering or equivalent technical discipline is required.
• Minimum of 1 year relevant work experience, preferably in biology/pharmaceutical industry.
• Experience in a QC testing environment preferred.
• Experience with aseptic technique in biosafety cabinets is strongly preferred.
• Knowledge of cGMP regulations and FDA/EU guidance related to cell-based products is strongly preferred.
• Knowledge of Good Tissue Practices is required.
• Excellent written and oral communication skills are required.

Responsibilities

• Complete QC testing related to manufacturing of autologous CAR-T products for clinical trials and commercial operation.
• Ensure testing is completed in compliance with procedures, standards and GMP regulations.
• Conduct analytical testing of raw material, in-process, or final product samples.
• Perform peer review/approval of laboratory data.
• Utilize LIMS for execution and documentation of testing.
• Create, review and approve QC documents, SOPs and WI's.
• Work safely and in accordance with quality systems and cGMP requirements.
• Collaborate with QA, Manufacturing Operations, and Analytical/Process Development.
• Be prepared for exposure to biological materials and hazardous chemicals.

Skills

LIMS experience

Analytical testing

Communication skills

cGMP knowledge

CAR-T QC knowledge

Education

Bachelor's Degree in Science, Engineering or equivalent technical discipline

Job description

Legend Biotech is seeking a QC Analyst as part of the Quality Operations team based in Raritan, NJ.

Role Overview

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

Key Responsibilities

• Be responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.


• Ensure testing is completed in compliance 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/approval of laboratory data.


• Utilize electronic systems (LIMS) for execution and documentation of testing.


• Create, review and approve relevant QC documents, SOP's and WI's.


• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.


• Work in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/Process Development.


• Job duties performed require routine exposure to and handling of biological materials and hazardous chemicals.

Requirements

• Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.


• Minimum of 1 year relevant work experience, preferably within a biological and/or pharmaceutical industry is required.


• Experience in a Quality Control setting is preferred.


• Experience with processing samples in biosafety cabinets utilizing 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 skill are required.


• Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.


• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.


• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.


• Comfortable with speaking and interacting with regulatory inspectors.


• This position may require occasional travel to partner sites in NJ or PA as business demands.


• This position may require up to 5% domestic or international travel as business demands.


• Takes responsibility for one's results and deliverables; sets and achieves goals to support organizational priorities.


• Takes initiative; willing to take unpopular positions/actions when necessary; courageous and assertive.


• Works effectively in the face of ambiguity, shifting priorities, and rapid change; maintains a positive outlook in difficult situations; a change agent.


• Identifies and focuses on activities of highest value and impact; makes informed decisions quickly.


• Results oriented; defines goals, metrics and actionable plans and manages work to deliver desired outcomes; has a sense of urgency.


• Considers resources, alternatives, constraints and desired outcomes to make effective decisions.


• Employs good project management principles to appropriately align time, resources, and budgets.


• Appreciates diverse perspectives and is actively inclusive of others' input and ideas; treats others with respect.


• Articulates ideas clearly and succinctly in a variety of settings and styles; can get messages across that have the desired effect.


• Leverages personal credibility and interpersonal skills to help others make better decisions and positively impact outcomes; able to develop/maintain effective working relationships internally and externally.


• Employs a global mindset in decision-making and errs on the side of over-communicating to create organizational transparency, trust and alignment.


• Takes initiative, actively shares knowledge, builds skills, promotes new ideas and embraces change.


• Generates new solutions to problems by challenging the status quo and conventional thinking.

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

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

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

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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