The Scientist Group Leader is responsible for the development and implementation of analytical procedures and specifications in support of the development and manufacture of active pharmaceutical ingredients (APIs) for traditional synthetic molecules (including potent) and peptides. Primary analytical techniques include chromatography (HPLC/UPLC, GC, and IC), Spectroscopy (LC-MS, GC-MS, NMR, ICP-MS, FTIR and UV-Vis), and physical properties (particle size, water content, etc.). Core Responsibilities:
- Lead the design, development, and execution of phase-appropriate analytical methods in compliance with ICH and Health Authority guidelines.
- Perform release and stability testing on starting materials, intermediates and API forboth development and GMP samples.
- Author and review technical documents including method qualification/validation/transfer protocols and reports for analytical procedures.
- Maintain and troubleshoot analytical instrumentation.
- Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed.
- Ensures work in compliance with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc.