Senior Scientist, QC

Full-time Other

Responsibilities

• Oversee GMP testing at CMOs and third-party testing sites for raw materials, components, in-process, and drug substance
• Verify and review analytical source data to ensure data integrity and compliance for product release
• Manage technology transfers and method improvements to ensure cGMP compliant methods are implemented
• Provide leadership for OOS investigations, change controls, deviations, CAPAs, and risk assessments
• Review and approve sampling instructions, test methods, specifications, and stability protocols
• Monitor emerging Quality and Regulatory requirements and determine impact to the company
• Ensure contracted laboratories follow appropriate quality practices and participate in regulatory inspections

Requirements

• Bachelor's degree in Biology, Chemistry, or related field with 6 years of experience (or MS with 5 years, PhD with 4 years) in biopharmaceutical analyt...