Scientist II, Analytical Development
Core
Analytical project leader responsible for developing, validating, and executing analytical chemistry research to support the manufacturing of API and drug products for preclinical and clinical studies.
Role type
Senior IC analytical development scientist (project lead)
Builds
Validated analytical methods and testing protocols for drug substances, intermediates, and final products
Domain
Biopharmaceuticals / Analytical Chemistry
Required skills
Analytical chemistry, method development, method validation, cGMP compliance, regulatory document preparation, project management, technical writing, laboratory equipment operation, impurity identification, toxicology supply characterization, contract service provider management
Preferred skills
Supervisory experience, pharmaceutical formulation knowledge, preformulation collaboration, cross-functional drug development understanding
Technologies
HPLC, GC, Mass Spectrometry, NMR, UV-Vis, dissolution testers, stability chambers, LIMS
Responsibilities
Develop and validate test methods for drug substances and products; Conduct structural characterization and impurity identification; Lead investigations for out-of-specification results; Audit and manage contract service providers; Prepare regulatory documents and reports; Train and supervise junior staff
Seniority
Senior, hands-on IC with project leadership
