What are the responsibilities and job description for the Senior Director or Vice President, CMC Development position at Warman O'Brien?
Company Overview
My Client is a dynamic, fast-growing biotech company dedicated to advancing innovative biologic therapies to address unmet medical needs. They are seeking a seasoned leader to oversee the Chemistry, Manufacturing, and Controls (CMC) strategy and execution as we advance our pipeline toward clinical development.
Position Overview
The Senior Director or Vice President of CMC Development will be a key member of the leadership team, responsible for shaping and executing the company’s CMC strategy for biologics. This role involves overseeing process development, manufacturing, quality, and regulatory aspects of CMC to ensure successful development and delivery of clinical and commercial products. The ideal candidate will have extensive experience in biologics development, a strategic mindset, and a hands-on approach suited to a small biotech environment.
Key Responsibilities
- Strategic Leadership : Develop and implement the CMC strategy to support the development, scale-up, and commercialization of biologic therapies.
- Process Development : Oversee upstream and downstream process development, formulation, and analytical development to ensure robust, scalable, and cost-effective manufacturing processes.
- Manufacturing Oversight : Manage relationships with Contract Development and Manufacturing Organizations (CDMOs) to ensure timely delivery of clinical and commercial material that meets quality standards.
- Regulatory Support : Partner with regulatory teams to contribute to the preparation of IND, BLA, and other regulatory submissions, providing CMC documentation and addressing agency questions.
- Quality Assurance : Ensure adherence to Good Manufacturing Practices (GMPs) and quality standards, collaborating closely with quality assurance teams.
- Budget and Resource Management : Manage budgets, timelines, and resources to ensure efficient and effective execution of CMC activities.
- Cross-Functional Collaboration : Work closely with R&D, clinical, regulatory, and commercial teams to align CMC activities with overall development goals.
- Team Leadership : Build and lead a high-performing CMC team, fostering a culture of innovation, accountability, and collaboration.
Qualifications
Benefits
If you are looking to take the next step in your career in the Biotech industry and you would like to know more about this role or the other opportunities we currently have on our books, please apply now with your CV to speak with our specialist Scientific Consultant William Ashbrook
Salary : $250,000 - $350,000
