Qc Supervisor, 2Nd Shift

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, 2nd Shift as part of the Quality 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.

This is a second shift position. The hours are 4 PM - 2 AM.

Key Responsibilities

• Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
• 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.
• Ensuring adequate training (skills-based, cGMP and safety) of associates within the department.
• 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.
• Other duties will be assigned, as necessary.
• 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 with corrective lenses.
• Work with cross-functional departments to support the manufacturing of autologous CAR-T products for clinical and commercial operation in a Controlled cGMP environment.
• Perform peer review/approval of laboratory data.
• Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.
• Represent and support Regulatory Inspections for QC.
• Utilize electronic systems (LIMS) for execution and documentation of testing.
• 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.
• Color Perception both eyes 5 slides out of 8
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations s,corrections and/or CAPAs.
• Create, review, and approve relevant QC documents, SOPs, and WI's.

Requirements

• Good written and verbal communication skills are required.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Key Capabilities, Knowledge, and Skills:
• This position may require occasional travel to partner sites in NJ as business demands.
• People management or leadership experience is required.
• Experience working with Quality systems is required.
• Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development is preferred.
• Knowledge of cGMP regulations and FDA/EU guidance is required.
• Experience: 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 with quality support in clinical/commercial manufacture or NPI is preferred.
• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
• Comfortable with speaking and interacting with inspectors.
• Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required.
• Education: A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• Knowledge of chemical, biochemical and cell and gene concepts is preferred.

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.

Benefits:

• Paid Maternity Leave
• Legal Insurance
• Long-Term Disability
• Life Insurance
• Critical Illness Insurance
• Employee Assistance Program
• Health Insurance
• Short-Term Disability
• AD&D Insurance
• Hospital Indemnity Insurance
• Paid Paternity Leave
• Health Savings Account
• Commuter Benefits
• Flexible Spending Account
• Pet Insurance
• Dental Insurance
• Vision Insurance
• Matched 401K
• Accident Insurance