The Fountain Group | CMC Operations Lead

3 weeks ago

waltham, United States The Fountain Group Full time

Currently I have an opening for a CMC Operations Lead located in Waltham, MA. Details for the position are as follows:

Job Description:

  • The Genomic Medicine Unit Chemistry Manufacturing & Control (CMC) development organization is responsible for all aspects of drug development, from molecule/pre-candidate to product approval.
  • This encompasses drug substance (DS), drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission to NDA approval.
  • Our mission is to serve patients through innovation in drug development and by designing state of the art manufacturing processes.
  • GMU CMC Operations Lead role will provides holistic support into the operational needs of the CMC organization to simplify workflows and enable scientists to achieve their deliverables.
  • Lead by example to promote an inclusive, motivating work environment that encourages participation, creativity, learning, and accountability.
  • Lead/support the champions teams for CMC and Research within GMU in Waltham.
  • Support information sharing (via share site and meetings) between support functions and champions team & functions heads.
  • Facilitate cross functional interactions within the 225 site and provide support between champion teams as required.
  • Work with champions and functional leads to develop solutions for bottlenecks to enable science.
  • Organize and relay feedback on managed services to various support functions to support adherence and compliance.
  • Support project teams, functional heads, and departments on establishing internal workflows and operations.
  • Collaborate with support functions such as HSE, Real Estate, Workspace Experience, Scientific services, etc. to support lab operations.
  • Bachelor’s degree required, masters preferred, with 5+ years of experience in R&D operations, management experience, and CMC.

Technical Information:

  • 12-month contract with potential for extension or conversion
  • Onsite, M-F, 8am-5pm
  • Pay: $40-48 hourly, depending on experience level

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