Job Title: VP CMC
Job Number: 31548
VP/Sr VP CMC will oversee the company’s CMC function. Reporting to the Chief Medical Officer, the candidate will be responsible for phase appropriate CMC development and manufacturing strategies, due diligence, identifying and implementing necessary process improvements, oversight of activities at contract development and manufacturing organizations (CDMOs), as well as authoring/review of relevant submissions to regulatory agencies.
- Experience in multiple CMC disciplinaries and platforms ideal, specifically biologics and small molecules across dosage forms (ie IV/oral/topical).
- Ability to scale out a team commensurate with the overall organizational growth – FTEs when needed and contractors to fill gaps
- Development and implementation of phase appropriate CMC development and manufacturing strategies from early clinical to commercial stages.
- Identification of assets in line with overall corporate strategy
- Identification of necessary process improvements, and management of development/ implementation of process improvements at external manufacturing sites.
- Oversight of proper execution of manufacturing runs at external CDMOs.
- In coordination with Supply Chain, Clinical Operations, Project Management and external CDMOs, forecasting of manufacturing needs and scheduling of manufacturing runs in accordance with program timelines budgets.
- Interaction as process development and manufacturing leader with internal and external parties, including Program Management, Analytics, Regulatory Affairs, Quality Assurance and Supply Chain.
- Identification and communication of risks in the manufacturing process and their mitigation.
- Responsibility to develop, author, review, and/or approve Standard Operating Procedures, specifications, reports, regulatory filings, or other controlled documents, as needed.
- Act as process and technical expert during regulatory inspections, regulatory agency meetings, and in creating responses to agency questions
- Representation of the company as overall manufacturing process expert during diligence and partner company interactions.
- M.S or equivalent in Chemistry, Biological Sciences, Engineering or related discipline, with 15+ years of experience; Ph.D. with 12+ years of experience.
- Ability to provide input on and set overall cmc corporate strategy.
- Oversight and knowledge in interacting and coordinating efficiently with Clinical Development, Clinical Operations, Bioanalytical, Non Clinical, Analytics, Regulatory Affairs, Program Management, Quality Assurance, and Commercial.
- Expertise in early development as well as late stage/commercial biologics, small molecules, vaccines or gene therapy, preferably in direct management of multiple disciplinaries and platforms.
- Experience managing a diverse team.
- Experience managing external contract organizations.
- Up to 20% travel to contract organizations within the US and to Europe required.
- Position based in NY or Remote.
- Excellent written and oral communication and collaboration skills across levels and functions.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Results oriented, has a bias for action. Strong initiative, accountability and willingness to take ownership and drive projects to completion.
- Accustomed “roll up their sleeves” and execute the tasks needed in a small company environment.
- Ability to set priorities, work independently and deliver results in a timely manner. Display a sense of urgency.