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Principal Tech Transfer Manager, Drug Product Manufacturing
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Our client, a leading Biotech focusing on the discovery and development of novel biologics, are seeking to hire a Principal Tech Transfer Manager - Drug Product Manufacturing.
You will be responsible for the transfer of Drug Product manufacturing processes from Development to internal or external GMP manufacturing facilities as well as the management and scientific support of CMOs/CROs for GMP manufacturing of Phase I, Phase II and Phase III clinical trial supplies.
Job Responsibilties:
- Provide expertise to support the selection process of Drug Product CMOs
- Lead interaction with CMOs for drug product manufacturing during different phases of product development.
- Lead and manage the technology transfer from Process Sciences to manufacturing team, and external CMOs
- Evaluate drug product development studies and make recommendations
- Collaborate with Process Sciences and provide input to ensure transferability to early and late stage manufacturing activities
- Manage external developments in the area of Drug Product manufacturing in collaboration with Process Sciences
- Lead process improvement and process characterisation of late Drug Product processes, in collaboration with Process Sciences
- Define the planning and organisation of tech transfer activities with the CMC project leaders
- Perform technology watch in the field of drug product manufacturing and monitor innovative technology development
Skills and Requirements:
- Degree in a analytical, pharmaceutical, chemistry, engineering or biochemistry subject with at industrial experience
- Experience in technology transfer and management of drug product manufacturing
- Experience with monoclonal antibodies
- Knowledge of process control methods and process validation
- Strong knowledge of GMP
- Experience in protein formulation and drug product development for both early and late phase development (Phase 1 to BLA)
- Active and independent problem-solving capabilities
- Exposure to the principles of QBD
- Must be available to travel abroad several weeks per year
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.
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