QC Supervisor
Company Information
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 and natural killer (NK) cell-based immunotherapy.
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) in 2017. 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 QC Supervisor as part of the Quality Operations team based in Raritan, NJ.
Role Overview
The QC Supervisor is an exempt level position with responsibilities for supervising the operation and workflow of the quality control laboratories in support of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data, developing and implementing QC procedures and methods, supporting laboratory investigations and ownership of various QC department projects.
Key Responsibilities
- Ensuring adequate training (skills-based, cGMP and safety) of associates within the department.
- Be responsible for managing scheduling of daily QC testing related to the manufacturing of autologous CAR-T products for clinical and commercial operation in a Controlled cGMP
environment. - Be responsible to manage direct reports on day-to-day basis, including mid-year and year-end performances assessments.
- Be responsible to create and manage development plans for direct reports.
- Be responsible for the completion of QC raw material/utility, in-process, or final product samples 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.
- Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
- Work with cross-functional departments to support the manufacturing of autologous CAR-T products for clinical and commercial operation in a Controlled cGMP environment.
- Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations, corrections and/or CAPAs.
- Represent and support Regulatory Inspections for QC.
- 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.
- Other duties will be assigned, as necessary.
- Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals
- Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better
- Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning.
Requirements
- A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
- A Minimum of 6 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance, or cell therapy. A minimum of 1 year of leadership experience is also required.
- Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development is preferred.
- People management or leadership experience is required.
- Experience working with Quality systems is required.
- Experience with quality support in clinical/commercial manufacture or NPI is preferred.
- Knowledge of chemical, biochemical and cell and gene concepts is preferred.
- Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required.
- Knowledge of cGMP regulations and FDA/EU guidance is required.
- 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 inspectors.
- Good written and verbal communication skills are required.
- This position may require occasional travel to partner sites in NJ as business demands.
- Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
- This position may require up to 10% domestic or international travel as business demands.
- Language: English
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Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech maintains a drug-free workplace.
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