Quality Control Manager (Contract)

Tessera Therapeutics • Somerville, MA

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About The Position

Tessera Therapeutics is hiring a Quality Control Manager for a 6-month contract, with the potential for conversion. As a member of the Quality Control team, this role leads aspects of QC laboratory operations and GMP method performance for analytical chemistry and molecular-based assays. The position manages GMP laboratory operations supporting internal testing of Tessera’s drug substances and drug products, helping keep testing on schedule and data quality high.

The role oversees QC laboratory operational activities, sample management and logistics, critical reagent programs, and review of QC data generated from compendial and platform assays for GMP release and stability testing. The successful candidate is a self-motivated quality professional who can multitask and work independently as well as cross-functionally.

Requirements

• A BS/BA degree with 4 or more years of related experience, an MS with 2 or more years of related experience, or a PhD with 3 or more years of related experience.
• Quality Control experience supporting GMP testing and/or manufacturing of gene therapy or gene editing products, ATMPs, or equivalent.
• Experience supporting or leading laboratory operations, such as GMP manufacturing or testing logistics, sample inventory management, and/or critical reagent program management.
• Ability to multitask effectively while working independently and cross-functionally.

Responsibilities

• Manage operational aspects of the QC laboratory, including laboratory maintenance activities.
• Schedule and coordinate GMP release and in-process testing.
• Oversee QC sample inventory management, sample transfer and receipt, and shipment of samples to external testing and storage sites.
• Manage critical reagent programs and trend method performance.
• Review QC data generated from compendial and platform assays to support GMP release and stability testing.
• Lead aspects of QC laboratory operations and GMP method performance for analytical chemistry and molecular-based assays.

What This Job Offers

• Career Level: Manager