Quality Control Manager (Contract)

Tessera Therapeutics • Somerville, MA

9d • $60 - $70

About The Position

The Quality Control Manager will lead aspects of QC laboratory operations and GMP method performance for analytical chemistry and molecular-based assays, managing GMP laboratory operations that support internal testing of Tessera’s drug substances and drug products. The role includes operational management of the QC laboratory, laboratory maintenance, and scheduling and coordinating GMP release and in-process testing. It also oversees QC sample inventory, sample transfers and receipt, and shipments to external testing and storage sites; manages critical reagent programs and trends method performance; and reviews data from compendial and platform assays to support GMP release and stability testing. This is a six-month contract role with the potential for conversion.

Requirements

• BS/BA degree with 4 or more years of related experience, MS with 2 or more years of related experience, or 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 logistics for GMP manufacturing or testing, 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 management and logistics, including inventory management, sample transfer and receipt, and shipment to external test 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.
• Support internal testing of drug substances and drug products through GMP laboratory operations.

What This Job Offers

• Career Level: Mid Level