Rx Group is supporting an exciting and highly innovative clinical stage biopharmaceutical organisation, headquartered in Cambridge, Massachusetts, with a VP Pharmaceutical Development to join them on a full-time basis.
The VP, Pharmaceutical Development will be responsible for providing strategic direction, technical leadership and operational execution of CMC development activities in support of The Company’s clinical programs. This individual will be responsible for collaboratively planning and executing phase appropriate development activities including process, formulation, and analytical development. This is a pivotal role in a clinical-stage company, with the unique opportunity to directly contribute to the success of programs, hire a team, and influence the culture of the department. This role reports to the Chief Technical Operations Officer.
Responsibilities
- Provide strategic, operational and research leadership to drive the end-to-end process and product development of the pipeline, utilizing internal and external teams, from pre-clinical stages to commercialization.
- Collaborate with Research, Manufacturing and Quality to ensure successful transfer of molecules, processes and analytical methods. In addition, provide required technical support for investigations related to manufacturing and Quality.
- Operate cross-functionally to design and implement CMC strategies and regulatory submissions aligned with world-wide regulatory requirements and industry best practices.
- Prepare and manage complex CMC development plans, budgets and long-range planning.
What you’ll need to be successful:
- 15+ years of proven experience in the pharmaceutical industry with a track record of developing and commercializing products along with 10+ years in a supervisory role managing (internal/external) CMC staff.
- PhD in pharmaceutics, chemical engineering, organic chemistry or related field.
- Prior experience in development and manufacturing of peptides is preferred.
Please apply directly or reach out to Hemish Ilangaratne at h.ilangaratne@rx-group.io for further information.
