QC Microbiology Lead
The QC Microbiology Lead at Legend Biotech is responsible for supervising the operation and workflow of the quality control microbiology laboratories supporting cell therapy manufacturing. This role involves hiring, developing, and managing staff performance, reviewing and approving laboratory test data, developing and implementing microbiology procedures and methods, supporting laboratory investigations, and overseeing various QC microbiology department projects.
Key responsibilities include ensuring adequate training of associates in skills-based, cGMP, and safety protocols; conducting raw material, in-process, environmental/utility, and product release testing; scheduling daily activities for personnel; investigating laboratory non-conformances; maintaining, calibrating, and qualifying laboratory instruments and equipment; verifying, qualifying, validating, and transferring test methods; and contributing to global strategies related to QC laboratories aligning with compliance and business objectives.
The ideal candidate will have a minimum of a Bachelor's Degree in Science, Engineering, or an equivalent technical discipline, along with at least 6 years of relevant work experience, preferably in an aseptic manufacturing facility within quality control, quality assurance, or cell therapy. A minimum of 1 year of leadership experience is also required. Extensive knowledge of chemical, biochemical, and microbiological concepts, as well as cGMP regulations and FDA/EU guidance, is essential. Strong organizational skills and the ability to work collaboratively in a team environment are also important.
The base pay range for this position is $93,463 to $122,670 USD. Additional compensation may include performance-based bonuses and/or equity for eligible roles. Benefits include medical, dental, and vision insurance, a 401(k) retirement plan with company match, paid parental leave, and a comprehensive paid time off policy. Additional voluntary benefits and well-being initiatives are also offered to support employees.