Quality Control Scientist I (Contract), System One Holdings, LLC, Gaithersburg, MD
System One Holdings, LLC -
Gaithersburg, MD,
US
Quality Control Scientist I (Contract)
Date Posted: 2024-06-15
Job description
Title: QC Scientist I
Location: Gaithersburg, MD
Schedule: Mon-Fri 8:00 am- 5:00 pm
Type: 6-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:
Requirements:
Location: Gaithersburg, MD
Schedule: Mon-Fri 8:00 am- 5:00 pm
Type: 6-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