QC Microbiology Lead, Cell Therapy

BioSpace

Raritan (NJ)

In loco

USD 110.000 - 140.000

Tempo pieno

15 ore fa

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Descrizione del lavoro

Legend Biotech, based in Bridgewater, NJ, seeks a Supervisor, QC Microbiology to lead the QC microbiology laboratories in support of cell therapy manufacturing. Responsibilities include staff development, data review, method development, and assay transfers.

This exempt role requires a Bachelor's in science/engineering, 6+ years in quality-related labs, and at least 1 year of leadership. Travel to NJ/PA may be required; strong communication and regulatory knowledge are essential.

Competenze

Bachelor's degree in Science, Engineering or equivalent technical discipline is required.
Minimum of 6 years relevant work experience; aseptic manufacturing facility preferred.
At least 1 year of leadership experience is required.
Experience with quality systems is required.
Knowledge of cGMP regulations and FDA/EU guidance is required.
Ability to apply mathematics to evaluate laboratory data.

Mansioni

Ensure proper skills-based, cGMP and safety training for staff.
Perform raw material, in-process, environmental, utility, and product release testing.
Schedule daily activities for personnel in the QC microbiology lab.
Investigate non-conformances, deviations and invalid assays.
Maintain calibration and qualification of instruments and equipment.
Oversee test method verification, qualification, validation and transfer.
Lead Process Performance Qualification and Continued Process Verification activities.
Collaborate with QA, Manufacturing, Technical Operations, Engineering and Maintenance.