Analytical Scientist
20 hours ago
Kaztronix is seeking a highly skilled QC Analytical Scientist to join our team in Gaithersburg, MD.
Job Summary:We are looking for a talented individual with a strong analytical and compliance background to support our Quality Control Analytical Technical Support team. The successful candidate will need to have a proven track record of troubleshooting and investigation skills, as well as experience with method validation and transfer.
Responsibilities:- Contribute to the QC analytical lifecycle management program
- Manage and lead method transfers and validations to internal and external laboratories
- Author transfer and validation protocols and reports
- Collaborate with Analytical Development on the introduction of new analytical technologies and instrumentation
- Troubleshoot and investigate trends in performance of analytical methods used for release and stability assays
- Provide analytical technical expertise for manufacturing deviations and OOS/OOT investigations
- Serve as a technical liaison between Quality Control and Analytical Development
- Represent QC on cross-functional teams focused on solving complex product and analytical issues
- Author deviations and investigations
- Work with Analytical Development to identify improvements in analytics that improve overall efficiency in QC Operations
- Work with development and manufacturing colleagues to implement analytical controls and support manufacturing and testing at CMOs
- Deliver analytical source documentation for CMC sections of IND/BLA filings and address technical inquiries from regulatory agencies
- 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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