Principal Scientist Process Chemistry
Principal Scientist - Process Chemistry
Late‑stage small‑molecule drug substance | On‑site | Relocation Assistance Available
SUMMARY
Our firm is currently partnered with a growing & highly collaborative CDMO looking for a new chemical development scientist to join their leadership team. The ideal candidate will be responsible for owning scale‑up for small‑molecule APIs from kilo lab into pilot/commercial assets, mentor chemists day‑to‑day, and act as a client‑facing technical voice for critical Phase 3 → launch programs. The lab is fully equipped, resourced, known for their high‑trust collaborative culture and team with deep scientific expertise. Hiring leaders are engaged and move quickly for the right person.
RESPONSIBILITIES
- Lead end‑to‑end route design and optimization, including multi-step synthesis, isolation, and purification strategies appropriate for scale‑up.
- Execute and oversee laboratory work (≈50%) while spending the remaining time on data review, documentation, and client updates (≈50%).
- Interpret advanced analytical/spectroscopic data to drive decisions on process robustness, impurity control, and crystallization/solid‑form considerations; author high‑quality technical reports suitable for external clients.
- Translate bench processes to plant operations, partnering closely with Manufacturing/GMP, EHS, and Analytical teams to de‑risk scale‑up and tech transfer.
- Provide hands‑on mentorship to junior chemists
- Represent programs in client meetings and cross‑functional CMC reviews; communicate progress, risks, and mitigations with clarity and credibility.
- Champion lab safety and compliant chemical handling/disposal practices; uphold high standards for data integrity and documentation.
QUALIFICATIONS
- Scale‑up must‑have: proven small‑molecule API scale‑up experience (kilo‑lab to pilot; Phase 2/3 to commercial readiness).
- Deep bench chemistry expertise in modern organic synthesis with a practical bias for manufacturability and impurity control.
- Strong analytical literacy (e.g., NMR/LC‑MS/HPLC) and the ability to turn data into go/no‑go decisions and clear client narratives.
- Credible project leadership and mentoring skills. High‑level written and verbal communication for client updates and internal governance.
- Degree flexible: industry experience is prioritized. PhDs + 5-6 years and MS/BS candidates with 10-15 years will be considered.
- Work authorization: H‑1B, TN Visas, and OPT holders are encouraged to apply.
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