Our client, a leading biopharmaceutical organisation, is in the process of in-licensing a new compound in oncology and is keen to hire a Principal Scientist/CMC Development.
- Plan, implement, develop and optimise the manufacturing processes for active substances derived from biotechnology
- Lead the biotech clinical active substances activities within project-dedicated CMC teams or early biotech developments
- CMC Project Leader and member of the corresponding Project Team
- Select the subcontractors, negotiate the offers and / or contracts
- Subcontract the planning and monitoring of the manufacture of GMP batches of biotechnology active substances for pre-clinical and clinical trials
- Define biotech active substance technical and regulatory strategies
- Lead or participate to the CMC evaluation (quality, costs and timelines) of potential new biotech project opportunities, including on site Due Diligences, for potential in-licensing.
- Scientific Degree in a biological science or equivalent
- Experience in biopharmaceutical products manufacturing and process development (mammalian cells), in various stages of project development
- Experience in manufacturing of monoclonal antibodies
- Comprehensive understanding of all aspects of CMC
- Experience in Project Management in a Bio-Pharmaceutic environment
- Ability to adapt to changing priorities and multitasking in a fast-paced, matrixed environment
- Proficiency with MS-Project Office tools.
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.