Senior CMC Project Lead

Our client, a leading Biotech focusing on the discovery and development of novel biologics, is currently seeking to hire a Senior CMC Project Lead. The incumbent of this role will be managing CMC product development for several products going into and through clinical development stages

Job Responsibilities:

• Working with the project teams to create alternative development scenarios, each comprising assessment of costs, timelines, risks and CMC documentation
• Coordinate with functional leads/line managers (R&D groups, PD, MFG, Quality, IMP) and external consultants to ensure timely execution of work packages
• Support the CMC program lead in defining the CMC program strategy and related, stakeholder management
• Manage all aspects of project management, process technology transfer and scale up procedures to CROs/CMOs
• Manage project CMC budget (actuals, accruals, forecast, short & long-term planning)
• Create/maintain state-of-the-art project management tools for CMC activities

Skills and Requirements:

• MSc/PhD or equivalent in biochemical engineering, biochemistry, biology, pharmacy or related discipline
• Relevant biologics R&D and CMC experience in an industrial setting
• In depth knowledge of current GMP guidelines, familiarity with regulatory authority submissions (IMPD/IND/BLA), quality and technical agreement drafting (CMO)
• Experience in process/analytical technology transfer and process scale up/validation
• Proficiency in state of the art project management tools

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Chidozie Orji on +44 207 4400 671 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.