Sr. CQV Specialist

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.

Legend Biotech is seeking a Sr. CQV Specialist as part of the Technical Operations team based in Raritan, NJ
.

This position will be responsible for providing Commissioning, Qualification and Validation support tothe 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, system sand 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 effectivencommunication, coordination and collaboration across relevant cross functional groups to establish astrong, compliant CQV program to enable robust production, testing and release of product to patients.

• 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.

• 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…