Tesseratherapeutics
Quality Control Manager (Contract)
Somerville, Massachusetts, United States. Posted 17 days ago
The role
You will lead aspects of QC laboratory operations and GMP method performance for analytical chemistry and molecular-based assays. This role manages GMP laboratory operations that support internal testing of drug substances and drug products.
What you will do
- Manage operational aspects of the QC laboratory
- Perform laboratory maintenance activities
- Schedule and coordinate GMP release and in-process testing
- Oversee sample management and logistics
- Manage QC sample inventory, transfer, receipt, and shipment to external sites
- Manage critical reagent programs
- Trend method performance
- Review QC data from compendial and platform assays to support GMP release and stability testing
Required qualifications
- BS/BA degree with 4+ years of related experience, MS with 2+ years of related experience, or PhD with 3+ 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 both independently and cross-functionally
About the company
Tessera Therapeutics is pioneering Gene Writing to offer scientists and clinicians the ability to write therapeutic messages into the genome. The company aims to create a new category in genetic medicine.