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Contract Process Chemist

Contract Process Chemist

Beacon HillCambridge, Massachusetts
30+ days ago
Job type
  • Full-time
Job description

Responsibilities

  • Solve technical issues related to drug substance manufacturing by providing hands-on laboratory support within the chemical development group including process design, optimization, scale-up, process intensification, process characterization, and spike-and-purge studies to bring a clinical phase program to commercial readiness.
  • Work with external CMO / CRO teams to enhance / support their laboratory experimentation
  • Author internal technical reports based on in-house laboratory research and provide critical review of similar reports generated at external CMO / CROs
  • Identify key knowledge gaps and execute plans to ensure process understanding is commensurate with a given program's stage of clinical development

Minimum Requirements

  • In-depth knowledge of synthetic organic chemistry
  • MS or PhD in organic chemistry with 5+ years (MS) or 3+ years (PhD) of industry experience
  • Demonstrated laboratory experience developing processes to produce small molecule pharmaceuticals from early to late-stage development
  • Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
  • Effective verbal and written communication skills
  • Demonstrated experience with organic chemistry instrumentation and interpretation including HPLC, LCMS, GC, NMR and applicable software (ChemDraw, Excel, Word, Powerpoint).
  • Demonstrated proficiency to manage timelines by effective prioritization to meet project goals
  • Preferred Qualifications

  • Working knowledge with DSC, TGA, and XRPD instrumentation and familiarity with MettlerToledo equipment are preferred.
  • Demonstrated scientific contribution to the synthetic community evidenced by presentations and publications
  • Regulatory writing experience including IND / IMPD / NDA / MAA drug substance quality modules.
  • PBOSJB_