Sr. Manager, QC Microbiology

Monitor QC method performance through trending analysis for on QC generated test results.

Represent department during internal and external audits.

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.

$142,146

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$186,567 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

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.

The role develops and implements long-term strategies and manages a team of people leaders and technical professionals within the QC department based on assigned work, direction, coaching and developing capabilities

Manage Raw material, in-process, environmental monitoring/utility, product release, and stability testing.

Manage and support Investigation of laboratory non-conformances (events, deviations, and invalid assays).

Maintenance, calibration and qualification of laboratory instruments and equipment.

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