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