2h ago
Principal Scientist, Analytical Development – Drug Substance
Remote
$169,000-$195,000 / year
full-timesenior Remotebiotechnology
Tech Stack
Description
You will lead analytical development for small molecule drug substances, driving method development, validation, and regulatory compliance to advance our CNS-focused pipeline from early to late-stage development.
Requirements
- PhD in Chemistry, Analytical Chemistry, or related field with 5+ years industry experience; or MS with 7+ years; or BS with 10+ years.
- Experience in pharmaceutical, biotech, or CRO/CMO with regulatory submissions and GMP/GLP.
- Direct experience with external manufacturing and analytical sites.
- Proficiency in HPLC, UPLC, GC, MS, UV/Vis, FTIR.
- Comprehensive understanding of ICH, FDA, EMA guidelines.
Responsibilities
- Lead development and optimization of analytical methods for starting materials, intermediates, and drug substances.
- Design and lead method validation activities to meet ICH, FDA, EMA guidelines.
- Oversee method development and transfer to manufacturing or quality labs.
- Author and review technical documents (SOPs, protocols, reports, specifications).
- Lead or contribute to multi-disciplinary project teams and manage timelines.
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