Head of CMC & Technical Operations
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Head of CMC & Technical Operations
About the Role
Remote (anywhere in Maryland)
The Company is seeking a Head of CMC & Technical Operations to lead the organization's CMC strategy and ensure the development and commercialization of its clinical programs. The successful candidate will be responsible for building and leading the teams and infrastructure necessary to support the full lifecycle of CMC activities, from IND-enabling to commercialization. This role requires a Ph.D. or equivalent advanced degree in a relevant scientific or engineering discipline, with approximately 20 years of experience in biopharmaceutical development, CMC, manufacturing, and technical operations. Experience in leading CMC activities for complex biologic products or technically demanding manufacturing platforms, particularly in the C> space, is highly valued. Key responsibilities for the Head of CMC & Technical Operations include providing leadership across technical functions, guiding CMC activities through the development lifecycle, and maintaining involvement in technical and operational challenges. The role also involves ensuring CMC activities are in compliance with quality and cGMP standards, providing senior leadership for regulatory strategy and submissions, and recruiting and mentoring technical leaders. The ideal candidate will have a broad technical understanding, the ability to lead multidisciplinary teams, and a proven track record in advancing programs from development to commercial launch. The position is well-suited for an executive who is adept at both strategic planning and hands-on execution in a dynamic biotech environment.
Functions:
- Operations
Compensation
USD $300,000-$450,000 (salary) per year
About the Company
Clinical-stage biotech building CMC capabilities for development and commercialization
Industry
Biotechnology
Type
Privately Held
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