GMP Analytical Chemist
Core
Utilize analytical methodologies and systems to support GMP release and stability testing of clinical supplies for drug substance and drug product throughout all phases of development.
Role type
GMP analytical chemist (wet chemistry)
Builds
Drug substance and drug product stability samples and analytical test results
Domain
Pharmaceutical manufacturing / Analytical chemistry
Required skills
GMP compliance, wet chemistry, HPLC, Raman spectroscopy, FTIR, compendial testing, dissolution testing, generic testing (solvents, water, ash, titrations, heavy metals, ICP/MS, UV), method development, method validation
Preferred skills
eLN, LIMS, data trending
Technologies
HPLC, Raman, FTIR, ICP/MS, UV
Responsibilities
Set up and analyze drug substance and drug product stability samples; Perform compendial testing for excipients and packaging; Execute generic testing for solvents, water, ash, titrations, heavy metals, ICP/MS, and UV; Develop and validate analytical methods for drug substance and drug product
Seniority
Individual Contributor
