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CK Group
,
Oxford, Oxfordshire
Associate Director, Product Development
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Job Type: Full-time |
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Salary: £65,000 per annum |
Overview
CK Group is recruiting for an Associate Director, Product Development and Supply to join an innovative biotech with a very promising lead candidate in a Phase II program with others in Phase I. This will be an office based role in Oxford on a permanent basis. This role would be ideal for a candidate with strong leadership skills and an extensive CMC drug development background. This is an excellent opportunity to join a small biotech with a focus in oncology, and a great opportunity for an highly experienced Manager in CDMO and CMC looking to make a step up to Associate Director level. Responsibilities: As Associate Director Product Development, your role will be to lead the CMC development of a late stage new chemical entity, as well as the management of all manufacturing and supply chain activities to clinical trial centres. The role will involve the active management of contract development and manufacturing organisations (CDMO), contracts, budgets, technical data and clinical trial supply activities. Your role and responsibilities will also encompass the following: Strategic planning, Product development, Regulatory/Compliance, Manufacture and Distribution. Some travel will be involved to sites to India and North America (less than 25%) Your Background: · B.Sc. in a biological or scientific field, Pharmacy degree a plus. · Experience in clinical supply chain planning and operations. · Experience in pharmaceutical/CMC drug development for clinical stage products up to commercialisation. · Experience in working and negotiating with third-party contract manufacturing sites and clinical supply operations, including in delivering technical agreements and product specifications. · Demonstrable and strong understanding and experience of GMP ensuring compliance to both these and internal SOP's/ICH. Job ref 47517 It is essential that applicants hold entitlement to work in the UK INDGEN