Associate Director, Product Development
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 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/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%)
- 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.
For more information or to apply for this position, please contact Naynesh Mistry on 01246 457703 or via email on firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47517 in all correspondence.