Sr. Manager, QC Microbiology

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop 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 pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, a Johnson & Johnson company, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). This partnership combines the strengths of both companies to advance an immunotherapy for the treatment of multiple myeloma.

The Sr. Manager, QC Microbiology is an exempt level position responsible for managing the operation and workflow of the quality control microbiology laboratories in support of cell therapy manufacturing. Key duties include hiring, development, and performance management of staff, reviewing and approving laboratory test data, developing and implementing microbiology procedures and methods, supporting laboratory investigations, and ownership of QC microbiology department projects.

The role creates and executes long‑term strategies and manages a team of people leaders and technical professionals.

• Ensure adequate training (skills‑based, cGMP and safety) of people leaders and associates within the department.
• Manage raw material, in‑process, environmental monitoring/utility, product release, and stability testing.
• Manage and support investigation of laboratory non‑conformances (events, deviations, and invalid assays).
• Maintain, calibrate and qualify laboratory instruments and equipment.
• Conduct test method verification, qualification, validation and/or transfer activities in the QC Micro laboratories.
• Perform Process Performance Qualification and Continued Process Verification activities associated with QC microbiology laboratory testing.
• Provide expertise in troubleshooting complex laboratory issues and demonstrate strong reasoning skills in support of ongoing laboratory investigations.
• Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while staying current with on‑the‑job training requirements.
• Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
• Contribute to global strategies related to QC laboratories that align with compliance and business objectives as well as the overall corporate vision.
• Manage departmental budget and resources; prepare staffing plans and adjust roles and responsibilities to meet business needs.
• Perform tasks in a manner consistent with safety policies, quality systems and cGMP requirements.
• Monitor QC method performance through trending analysis of QC‑generated test results.
• Represent department during internal and external audits.
• Work routinely with biological materials and hazardous chemicals.
• Collaborate with quality counterparts across multiple functions.
• Perform other duties as assigned.

• Minimum Bachelor’s Degree in Science, Biology or an equivalent technical discipline.
• 12 to 14 years of relevant experience, preferably in aseptic manufacturing, microbiology quality control laboratory, quality assurance or cell therapy, and 3–5 years of leadership experience.
• Experience with quality systems.
• Extensive knowledge of chemical, biochemical and microbiological concepts.
• Ability to apply basic and advanced mathematical concepts (including statistics) in evaluating laboratory data.
• Knowledge of cGMP regulations and FDA/EU guidance.
• Comfortable speaking to inspectors and presenting findings.
• Good written and verbal communication skills.
• Up to 10% domestic or international travel may be required.
• In‑depth knowledge of cGMP and cGTP related to CAR‑T manufacturing or cell processing.
• Proven people‑management and leadership experience.
• Preferred: experience in biopharmaceutical analysis method verification,…