Quality Control Scientist I

Title: QC Scientist I

Location: Gaithersburg, MD

Schedule: Mon-Fri 8:00 am- 5:00 pm

Type: 12-month Contract

Start: Immediately

 

Overview:

Our client a leading biotechnology company in Gaithersburg, MD is looking to add a Quality Control Scientist I to their team! The successful candidate will need a strong analytical and compliance background with proven troubleshooting/investigational skills. This position will support Quality Control through involvement with complex analytical and/or manufacturing investigations, method troubleshooting, method validation/transfer, and authoring of CMC analytical sections in support of regulatory filings/responses.

 

Responsibilities: Lead QC analytical lifecycle management program, including method transfers and validations for internal and external labs. Author and manage transfer/validation protocols and reports, and represent QC on cross-functional teams to resolve complex product and analytical issues. Collaborate with Analytical Development on new technologies, instrumentation, and efficiency improvements in QC Operations. Troubleshoot and investigate analytical method performance trends and manufacturing deviations, working with Manufacturing and Quality Assurance. Act as a technical liaison between Quality Control and Analytical Development, authoring deviations and investigations. Implement analytical controls and support manufacturing/testing at CMOs in collaboration with development and manufacturing colleagues. Provide analytical documentation for CMC sections of IND/BLA filings and address regulatory inquiries. Requirements: B.S. in Biochemistry, Chemistry, or related scientific discipline with at least 6 years of experience in the biopharmaceutical industry Demonstrated scientific knowledge and experience in analytical methodologies used for Large molecules Demonstrated broad knowledge and experience in method transfers and validations Established knowledge of applicable global drug development and regulatory standards and current expectations Established knowledge and application of cGMPs/GLPs, ICH, FDA CMC Guidance Documents #M3