Cambridge, Massachusetts
3 days ago
Contract Process Chemist

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Our client is searching for a dynamic Contractor Process Chemist to join the growing Process Research and Development team. The Senior Scientist / Principal Scientist will be able to follow programs as they proceed through development as supporting the overall drug substance development and manufacturing activities. The successful candidate needs to demonstrate a proven track record of solving technical challenges while supporting GMP manufacturing.

Key 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 experimentationAuthor internal technical reports based on in-house laboratory research and provide critical review of similar reports generated at external CMO/CROsIdentify 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 chemistryMS or PhD in organic chemistry with 5+ years (MS) or 3+ years (PhD) of industry experienceDemonstrated laboratory experience developing processes to produce small molecule pharmaceuticals from early to late-stage developmentAbility to navigate and be successful in a fast-paced, highly-matrixed work environmentEffective verbal and written communication skillsDemonstrated 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 Mettler‑Toledo equipment are preferred.Demonstrated scientific contribution to the synthetic community evidenced by presentations and publicationsRegulatory writing experience including IND/IMPD/NDA/MAA drug substance quality modules.

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