Legend Biotech US is seeking a QC Microbiology Lead for an exempt-level position responsible for supervising the operation and workflow of our Quality Control microbiology laboratories. This role is critical in supporting our cell therapy manufacturing. You will manage staff, approve laboratory test data, develop procedures, support investigations, and own key departmental projects.
What You'll Do
- Ensure adequate cGMP, safety, and skills-based training for departmental associates.
- Oversee raw material, in-process, environmental/utility, and product release testing.
- Schedule daily activities for laboratory personnel.
- Investigate laboratory non-conformances including events, deviations, and invalid assays.
- Manage maintenance, calibration, and qualification of laboratory instruments and equipment.
- Lead test method verification, qualification, validation, and transfer activities.
- Support Process Performance Qualification and Continued Process Verification activities.
- Provide expertise in troubleshooting complex laboratory issues and support ongoing investigations.
- Maintain knowledge of industry guidelines, regulatory requirements, and applicable pharmacopeia.
- Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering, and Maintenance.
- Contribute to global QC laboratory strategies aligning with compliance and business objectives.
- Manage departmental budget, resources, and staffing plans.
- Perform tasks consistent with safety policies, quality systems, and cGMP requirements.
What We're Looking For
- A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline.
- A minimum of 6 years of relevant work experience.
- A minimum of 1 year of leadership experience.
- People management or leadership experience.
- Experience working with Quality systems.
- Extensive knowledge of chemical, biochemical, and microbiological concepts.
- Ability to apply basic and advanced mathematical concepts, including statistics, to lab data.
- Knowledge of cGMP regulations and FDA/EU guidance.
- Highly organized with ability to work in a team with a positive attitude under some supervision.
- Comfortable speaking and interacting with inspectors.
- Good written and verbal communication skills.
- Ability to accommodate unplanned overtime, including nights and weekends, on little notice.
- Distance visual acuity of at least 20/30 (Snellen) in both eyes, corrected or uncorrected.
- Color perception of at least 5 slides out of 8.
Nice to Have
- Experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance, or cell therapy.
- Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development.
- Experience with quality support in clinical manufacture or New Product Introduction (NPI).
Team & Environment
You will be part of the Quality team, working collaboratively with counterparts in Quality Assurance, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain, and Planning. Job duties routinely require exposure to and handling of biological materials and hazardous chemicals.
Work Mode
This is an onsite position located in Raritan, NJ.
Legend Biotech US is an equal opportunity employer.
