Principal Scientist, Process Process Chemistry
Principal Scientist, Process Chemistry 1326792
Location: Greater Boston, MA (Onsite)
Science: Small Molecule
Job Overview: This process chemist will contribute to process development efforts to develop scalable, cost-efficient, environmentally-sound synthetic processes for small molecule drug substance programs.
- Collaborate cross functionally with internal and external teams to drive the development, scale-up and syntheses of small molecule drugs
- Coordinate the planning, execution of tech transfer and process validation with CDMO’s
- Support regulatory documentation needed for INDs, NDAs, IMPDs, and NDAs
- PhD with 5+ years of relevant industry experience in pharmaceutical small molecule process development from early phase route scouting through process optimization and scale-up
- Strong experience in technology transfer and process development and working with external partners to achieve process development goals and manufacturing
- Familiarity with the preparation of process, analytical, and characterization reports suitable to support regulatory filings.
- Strong background in cGMP and ICH guidelines
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