Analytical Scientist

20 hours ago


Gaithersburg, Maryland, United States Kaztronix Full time
Job Title: QC Analytical Scientist

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
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
  • 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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