QC Microbiology Lead

Legend Biotech US • Raritan, NJ

2d • Onsite

About The Position

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 QC Microbiology Lead as part of the Quality team based in Raritan, NJ.
Role Overview
The QC Microbiology Lead is an exempt level position with responsibilities for supervising the operation and workflow of the quality control microbiology laboratories in support of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data, developing and implementing microbiology procedures and methods, supporting laboratory investigations and ownership of various QC microbiology department projects.

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.
• People management or leadership experience is required.
• Experience working with Quality systems is required.
• Extensive knowledge of chemical, biochemical and microbiological concepts is required .
• 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 or PA 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 10% domestic or international travel as business demands.
• 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.
• Color Perception both eyes 5 slides out of 8.

Nice To Haves

• Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development is preferred.
• Experience with quality support in clinical manufacture or NPI is preferred .

Responsibilities

• Ensuring adequate training (skills-based, cGMP and safety) of associates within the department.
• Raw material, in-process, environmental/utility, and product release testing.
• Scheduling of daily activities for personnel.
• Investigation of laboratory non-conformances (events, deviations, and invalid assays).
• Maintenance, calibration and qualification of laboratory instruments and equipment.
• Test method verification, qualification, validation and/or transfer activities in the QC laboratories.
• Process Performance Qualification and Continued Process Verification activities associated with QC microbiology laboratory testing.
• Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations.
• Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in 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 which align with compliance and business objectives as well as the overall corporate vision.
• Manage departmental budget and resources; prepare staffing plans. Make adjustments to roles and responsibilities of department to meet business needs.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Other duties will be assigned, as necessary.
• Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level