Sr. CQV Specialist

Sr. CQV Specialist Employer Legend Biotech Location Raritan, New Jersey Salary $110706 - $145303 Start date May 22, 2026 View more categories View less categories Discipline Clinical , Clinical Medicine 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. CQV Specialist as part of the Technical Operations team based in Raritan, NJ . Role Overview This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require CQV experience, represent CQV work in the regulator and internal audits, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and release of product to patients. Key Responsibilities Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant. Manages multiple and complex CQV projects, collaboration with cross functional teams, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks. Supports and/or owns technical and quality investigations, CAPAs and corrections. Develops and performs any required remediation efforts and associated CAPA plans. Authors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity. Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation. Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews. Train and support the junior team members on different CQV activities. Present CQV work to regulatory and internal audit teams. Other responsibilities as assigned. Making decision on corrective action in deviation events. Make decisions on technical approach, methodology per applicable procedure. Manager approval required for resource assignment, timeline shift, strategic shift and finance related events. Requirements A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required. A minimum of 7 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance. Ability to use following or similar systems for business needs: Microsoft suite & ERP systems: Maximo, Siemens EMS, Comet, Kneat & Testing system: Kaye AVS, Kaye Valprobe. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices. Strong interpersonal and written/oral communication skills. Ability to quickly process complex information and often make critical decisions with limited information. Proficient in applying process excellence tools and methodologies. Ability to independently be responsible for a portfolio of ongoing projects. Ability to pay attention to details and follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision. Good written and verbal communication skills are required. Ability to summarize and present results, and experience with team-based collaborations is a requirement. Ability to work with others in a team environment. Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing. Ability to identify/remediate gaps in processes or systems. Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred. Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, CQV protocols. #Li-RN1 #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): $110,706 - $145,303 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