Director, CMC Project Management

Our Small Molecule Pharma client is seeking a Director/Sr. Director, CMC Project Management to join their Cambridge, MA team (remote-base possible as well).  This role will be responsible for the development and execution of multiple CMC development and pharmaceutical operations plans as well as regulatory activities. The Director will lead a team of project managers and will work closely with subject matter experts in chemical and formulation development, analytical development, technical operations and supply chain. Director will be responsible for comprehensive communication, including status reporting, risk management and escalation of issues to cross-functional stakeholders and Senior Management. Director will create processes to streamline project management and be accountable for project development and timelines for pharmaceutical development and pharmaceutical operations team members. The Director will become a Go-To person for the team, providing input on content, advice, and leveraging his or her in-depth experience of CMC projects.  Other responsibilities include but not limited to: 

  • Independently lead sub-teams.
  • Work closely with Senior Management and project teams to develop goals, execution plans, budgets.
  • Represent CMC on multiple cross-functional teams.
  • Regularly interact with the following functions: Chemical Development, Formulation Development, Analytical Development, Technical Operations, Supply Chain, Regulatory, Quality, Clinical Operations.
  • Conduct scenario planning and provide analysis and recommendations on development plans and periodically present to management to ensure alignment.
  • Based on CMC strategy, (1) prepare and maintain detailed project timelines, (2) track the status of all ongoing development and manufacturing activities and regularly present project status updates, (3) ensure cross-functional alignment within the organization and with global partners.
  • Develop strong understanding of our strategy, pipeline and capabilities, and actively leverage this knowledge to inform priorities for activities.
  • Maintain detailed project documentation for knowledge management. Provide document support as needed.
  • Manage, develop, and mentor direct reports.

Requirements:

  • B.S. and 8+ years of pharmaceutical development, operations or CMC project management experience OR; M.S. 6+ years pharmaceutical development, operations or CMC project management experience OR; Ph.D. 3+ years pharmaceutical development, operations or CMC project management experience.
  • Degree in organic, inorganic, analytical chemistry, biochemistry, chemical engineering.
  • Excellent communication skills, both verbal and written.
  • Experience mentoring team members.
  • Working knowledge of ICH guidelines, module 3 sections, preparation of investigational new drug applications. Participation of new drug application preparation is a plus.