Overview In this role, you contribute to late-stage analytical development within the iPAS team in Thousand Oaks, advancing analytical tools and strategies for drug substances and products. You collaborate across drug substance and product development to support regulatory milestones and pivotal clinical programs. You'll drive method development, transfer, and CMC input, aiming to ensure quality and successful market authorization. The position offers exposure to cross-functional leadership and a chance to shape analytical strategies that impact patient outcomes.
Compensation / Benefits- Total Rewards Plan with health and welfare coverage
- stock-based long-term incentives
- discretionary annual bonus
- flexible work models where possible
- retirement and savings plan with company contributions
- comprehensive time-off policies
Responsibilities- Define analytical control strategies for late-phase programs and articulate associated challenges
- Develop, optimize, and authorize analytical methods for small molecules, peptides, and siRNA release testing
- Collaborate with CDMO/CTL to transfer methods and review their protocols and reports
- Provide analytical data to support drug substance and product development, including purity and structure elucidation via mass spectrometry
- Lead and mentor a small group of scientists and potentially lead method transfer activities
- Contribute to regulatory documentation (CMC sections) and technical reports
- Support cross-functional project teams to achieve objectives
Key requirements- PhD in Analytical Chemistry or related discipline (preferred)
- 2+ years post-PhD experience in pharma/biotech focusing on process/product development and analytical method development
- Experience with method development, validation, and transfer for in-process, release, and stability testing
- Experience in peptide method development and MS-based characterization
- Strong knowledge of structure elucidation, MS, UV, NMR, FTIR; familiarity with USP/ICH/FDA guidance
- Understanding of GLP/GMP and ability to manage tech transfer to external CMOs/CTLs
- Excellent scientific writing and cross-functional communication skills
- Ability to work across global teams and time zones
- strong communication
- cross-functional leadership
- attention to detail
- Mass spectrometry (MS)
- Ultraviolet spectroscopy (UV)
- Nuclear magnetic resonance (NMR)
