Manager of QC Microbiology

Legend Biotech is seeking Manager of QC Microbiology as part of the Quality team based in Raritan, NJ.

Role Overview

The Manager, QC Microbiology is an exempt level position with responsibilities for managing 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.

Key Responsibilities

• Ensuring adequate training (skills-based, cGMP and safety) of associates within the department.
• Raw material, in-process, environmental/utility, product release, and stability testing.
• 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.

Requirements

• A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
• A Minimum of 10 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 to 4 years 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 manufacture or NPI is preferred.
• 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 up to 10% domestic or international travel as business demands.

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