Principal Scientist - Analytical Development (Small Molecule)
Principal Scientist - Analytical Development
Late-stage small‑molecule CDMO | On‑site I Relocation Assistance Available
SUMMARY
Our firm is currently partnered with a growing & highly collaborative CDMO expanding the Analytical leadership team. In this role you'll split your time ~50% at the bench and ~50% on strategy/client updates/documentation, while overseeing and mentoring 3-4 junior chemists per project. You'll shape late‑stage analytical readiness for raw materials, intermediates, and APIs and transfer those methods into routine QC use.
RESPONSIBILITIES
- Develop, validate, and transfer analytical methods for APIs, intermediates, and raw materials; generate clear, decision‑ready technical reports and complete laboratory notebooks.
- Run/troubleshoot advanced instrumentation (HPLC, GC, GC/MS, FTIR, titration, particle‑size analysis) and transfer methods to QC/Process Support for routine execution
- Lead investigations and partner cross‑functionally with Analytical Development, Chemical Development, Process Support, and Quality Control to resolve analytical issues at speed.
- Coordinate off‑site testing, qualify reference standards, and maintain strict cGMP/SOP/DEA compliance across deliverables.
QUALIFICATIONS
- Education/Degree Flexible: PhD (~6-8+ yrs), MS (~10-12+ yrs), or BS (~12-15+ yrs) in Chemistry or related field.
- Must‑have: Hands‑on Karl Fischer (KF) titration experience (method development/validation and troubleshooting).
- Proven track record to develop, validate, and transfer robust methods in a GMP environment; leads analytical investigations and can steer clients toward sound outcomes.
- Advanced command of HPLC, GC, MS (operation, troubleshooting, training others).
- Clear, client‑facing communication; authors high‑quality technical documentation with minimal rework.
- Work authorization: H‑1B, TN Visas, and OPT holders are encouraged to apply.
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