Independently develops, tests, validates and approves new test methods
Advise on project decisions with potential regulatory consequences
Write, review, and approve technical reports, summaries, protocols, and other documents
Serve as contact for vendors and contract laboratories
Lead communications and strategy for external and internal audits
Identify and drive process improvements, leveraging Lean/Six Sigma methodologies

Bachelor’s or graduate degree in chemistry or related field
Ten or more years of related analytical laboratory experience
A minimum of six years in a pharmaceutical environment is preferred
Demonstrated understanding of drug product formulation development
Experience with FDA regulations, USP, NF, ICH, EP, and their application in the laboratory.
Skills in test method development and validation
Advanced proficiency with data analytics tools and process improvement methodologies.

Compliance Scientist I – MST

Key skills