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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