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QC Analytical Scientist
Job Description
Quality Control Scientist I
Must meet 6 yrs in pharma lab.
In the Quality Control Analytical Technical Support team in Gaithersburg, MD. 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. This position will report to the Manager of Method Introduction and Support.
The primary focus of the role will be to provide technical expertise to both internal and external labs in support of method lifecycle management and laboratory/manufacturing investigations.
Responsibilities include but are not limited to:
Must meet 6 yrs in pharma lab.
In the Quality Control Analytical Technical Support team in Gaithersburg, MD. 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. This position will report to the Manager of Method Introduction and Support.
The primary focus of the role will be to provide technical expertise to both internal and external labs in support of method lifecycle management and laboratory/manufacturing investigations.
Responsibilities include but are not limited to:
- Contribute to the QC analytical lifecycle management program
- Responsible for the management/leadership of method transfers and validations to internal and external laboratories.
- Authors transfer/validation protocols and reports
- Collaborates with Analytical Development regarding the introduction of new analytical technologies and instrumentation
- Troubleshoots and investigates trends in performance of analytical methods used for release/stability and in-process assays
- Provides analytical technical expertise for manufacturing deviations and OOS/OOT investigations by working in concert with Manufacturing and Quality Assurance
- Serves as a technical liaison between Quality Control and Analytical Development
- Represents QC on cross functional teams focused on solving complex product and/or analytical issues
- Authors deviations and investigations
- Works in collaboration with Analytical Development to identify improvements in the analytics that improve overall efficiency in QC Operations
- Works in collaboration with development and manufacturing colleagues to implement analytical controls, and support manufacturing and testing at CMOs
- Delivers analytical source documentation for CMC sections of IND/BLA filings and addresses technical inquiries from regulatory agencies to support clinical trial and commercial marketing applications
- Builds and maintains strong working relationships with colleagues in Research and Development, Regulatory CMC, Quality as well as alliance partner counterparts, as applicable
- 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
- Experience with CMC technical sections of regulatory submissions and addressing regulatory authorities on technical matters
- Strong analytical and strategic thinking
- Demonstrated problem solving capabilities and cross functional understanding
- Excellent communication skills (oral, written, presentation)
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