CMC Director, Pharmaceutical Development
Experienced CMC Director from small molecules wanted for a global biotechnology company.
CK Group are recruiting for a Director of CMC & Pharmaceutical Development, to join a global Biotechnology company based in Cambridge on a permanent basis.The Company: Our client is an early-stage drug development company targeting a unique pathway for the treatment of a range of specific neurological and pulmonary diseases.
Location: This role is located in Cambridge.
The Role:
- Leadingall CMC and pharmaceutical development activities for clients portfolio of development compounds
- Interact across R&D and taking lead on CMC & pharmaceutical development activities i.e. supporting candidate selection through to clinical development, partnering closely with key stakeholders
- Lead pharmaceutical development planning and implementation and support for all development compounds (from those approaching nomination through all stages of clinical development)
- Managing the technical and quality aspects in API process development/ manufacture, formulation development, packaging and labelling of Investigational Medicinal Product (IMP), and analytical development and validation
Your Background:
- Degree in appropriate technical subject (e.g. Chemistry, Biochemistry, Pharmacy). Postgraduate qualification would be a benefit
- Extensive experience in biotech / pharma CMC, with a focus on small molecule pharmaceutical and formulation development (10 years+).
- Knowledgeof GMP requirements for drug substance and drug product manufacturing.
- Experience of managing CDMOs, generating and compiling regulatory documentation, and ensuring quality
Apply: Entitlement to work in the UK is essential. For more information or to apply for this position, please contact Naynesh Mistry on 01246 457703 or email nmistry@ckgroup.co.uk. Please quote reference 52483.