Sr. QC Analyst

Sr. QC Analyst Employer Legend Biotech Location Raritan, New Jersey Salary $96267 - $126351 Start date May 12, 2026 View more categories View less categories Discipline Quality , Quality Control Required Education Bachelors Degree Position Type Full time Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. QC Analyst as part of the Quality team based in Raritan, NJ . Role Overview The Sr. 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. #Li-RP1 #Li-Onsite The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay:

Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off:

Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, 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, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Pay Range (Base Pay): $96,267 - $126,351 USD 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. For information related to our privacy notice, please review: Legend Biotech Privacy Notice . Company Legend Biotech was founded as an early-stage cell therapy company in 2014. The company was the brainchild of visionary scientists who recognized that antibody-based therapeutics could potentially treat disease and possessed the backgrounds in immunology and gene editing to take the leap. For two years, Legend Biotech, then known as the "Legend Project," operated in a room the size of a freight elevator, with the goal of creating a cell therapy for multiple myeloma, a hematological cancer that often relapses and can become refractory. The team produced nanobodies for single-domain antibody drugs and ultimately extended the half-life of the nanobodies with proprietary technologies. In 2015, Legend's scientists focused on research for chimeric antigen-receptor T-cells (CAR-T) targeting the BCMA protein, making the biotech one of the first companies in the world to engineer CAR-T cells for the BCMA protein. In 2016, investigator-initiated trials began in China. In 2017, data from the trials were presented at the American Society for Clinical Oncology (ASCO), which led to a partnership with biopharmaceutical company Janssen Biotech, Inc. to co-develop the anti-BCMA CAR-T, ciltacabtagene autoleucel (cilta-cel). Applications seeking approval of cilta-cel for the treatment of patients with RRMM are currently under regulatory review by several health authorities around the world.

CARVYKTI

™ (ciltacabtagene autoleucel) was approved by the U.S. Food and Drug Administration in February 2022 and received conditional marketing approval from the European Medicines Agency in May 2022. Today Legend Biotech is a global, commercial-stage company driven by a passion for patients. We continue to build our pipeline of cell therapy platforms, which includes CAR-T, CAR-NK, CAR-γδ T and non-gene-editing CAR technologies. Our goal is to bring hope and opportunity to patients and their families by continuing to explore unique technologies. Company info Location Somerset New Jersey United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert