Position Summary:

Looking for a hardworking, results-focused analytical chemist to support pharmaceutical programs. The position is on-site and lab-based, requiring relevant expertise in vibrational (FTIR and/or Raman) spectroscopy and compendial analytical techniques to support release testing of raw materials, excipients, intermediates, and starting materials used in the manufacturing of clinical drug substances and drug products.

Essential Functions:

• Independently perform analytical testing including but not limited to FTIR and Raman spectroscopy methods, color & physical appearance tests, pH and osmolality measurements, compendial wet chemistry identification methods (e.g., USP<191>), and other general analytical lab techniques. Executed tests will support clinical release and stability testing of drug substances, drug products, excipients and raw materials used in the manufacturing and formulation of Clinical drug substances and drug products.
• Demonstrate practical knowledge of analytical techniques contributing to the development of phase-appropriate robust and reproducible analytical methods used in a GMP testing laboratory.
• Maintain clear, complete, accurate and GMP-compliant documentation for experiments.
• Independently execute analytical method qualifications, verifications, and validations (as applicable), carefully adhering to approved protocols.
• Contribute to study design and the authoring of analytical protocols and reports.