We’re seeking a detail-oriented and motivated individual to support analytical & microbiological testing, and lab operations in a GMP environment. This role involves performing TVC, Appearance, Coliform and Choline microbial testing and GMP analytical testing. The ideal candidate has hands-on analytical and microbiology experience, strong documentation skills, and thrives in a fast-paced, team-oriented setting.
- Ability to work in a GLP or GMP environment with appropriate documentation and safety practices.
- Experience with GMP, microbiological testing, wet chemistry, HPLC, Raman, FTIR
- Responsible for water testing in support of manufacturing facilities including total viable counts (including filtration and pour plate), appearance, coliform and chlorine testing.
- Responsible for utilizing analytical methodologies, systems, and processes to support GMP release and stability testing of clinical supplies for drug substance and drug product, throughout all phases of development. This may include excipient, packaging, and post-packaging support.
- Analytical testing would include: compendial testing (e.g., excipients/packaging release testing), disintegration, dissolution, HPLC/UPLC, SFC, generic testing (e.g., solvents, water, ash, titrations, heavy metals, ICP/MS, UV), and compound-specific methods.
- Set up and analysis of drug substance and drug product stability samples.
- Method development and validation of analytical methods for drug substance and drug product