Job Description

Responsibilities

Design and develop phase-appropriate analytical methods supporting early pharmaceutical development activities
Execute developability assessment studies including solubility, stability, excipient compatibility, and form selection
Identify and communicate emerging pharmaceutical development data and risks to broader R&D team
Review and author technical documentation including regulatory submissions and scientific reports
Research and implement new instrumentation and analytical technologies to support development programs

Requirements

BS in Chemistry, Biochemistry, Chemical Engineering, or related field with 4+ years pharma industry experience in chemistry/analytical laboratory
MS in Chemistry, Biochemistry, Chemical Engineering, or related field with 2+ years similar experience; or PhD with relevant postdoc experience
Technical expertise in analytical method development and preformulation sciences
Proficiency with LC-MS and HPLC (SEC, UV, MS, IEX); working knowledge of DSC, TGA, PXRD, NMR, and particle-size analysis
Strong knowledge of regulatory guidelines for INDs, CTAs, NDAs, and BLAs preparation and authoring
Familiarity with multiple pharmaceutical dosage forms and fit-for-purpose method qualification/validation
Ability to work independently and collaboratively in fast-paced, matrixed team environment

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