Associate Director/Director, CMC

A Fantastic opportunity for a Associate Director/Director, CMC to have a significant impact in the next phase of expansion for an International Biopharmaceutical company, who has undergone a recent successful major funding round. Associate Director/Director, CMC Cambridgeshire Salary depends on experience Yoh Life Sciences are supporting this company as they grow the UK arm of the business. They are experts in the discovery and early development of new medicines across multiple therapeutic areas. The Associate Director/Director, CMC will lead Drug Substance Design and CMC from candidate nomination through to clinical development across several therapeutic areas. As part of the Preclinical Development Group, this position will ensure integration of drug substance CMC strategy and operations within overall drug development strategy and timelines across all projects. Key responsibilities for the Associate Director/Director, CMC will include: Manage and lead the drug substance, small molecule and peptide, CMC aspects of late stage lead optimisation, preclinical and clinical projects, to agreed timelines and budget. Manage and provide scientific problem-solving contributions to the Drug Substance Design and CMC specialism Play an active role in the candidate selection phase of lead optimisation projects to ensure the best molecules are selected for preclinical development Lead Drug Substance discipline in business development interactions and collaborations with partner companies. Regulatory compliance - author, review, and support CMC section of regulatory documentation to ensure generation of high-quality Module 3 drug substance sections of IMPD and IND submission documents. To be considered for this role you will need: Minimum of BSc in synthetic organic chemistry (or related discipline) with significant experience in drug substance CMC. Experience working with small molecules Understanding of requirements for safe scale-up of process chemical processes. In depth understanding of relevant GMP requirements for manufacture of drug substance for use in clinical trials Understanding of relevant regulatory requirements for manufacture of drug substance for use in clinical trials. Strong knowledge of process Chemistry If this role sounds of interest then please apply

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