The Head of Biotech Chemistry Manufacturing & Control – Ref.: JVM310718N
The role holder will be responsible for CMC-related activities for a novel programme employing an engineered silica nanoparticle, which has been designed for the intracellular delivery of large nucleic acids such as pDNA and mRNA and is in the advanced research phase. The role requires someone with an understanding of stability, process improvement, prototype formulation and manufacture and supply of clinical trial materials.
The ideal candidate will be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities. Qualified in a relevant biological scientific discipline; the role demands relevant experience in CMC for polymer delivery systems and formulations or biologicals or ideally both but with emphasis on the pharmaceutical manufacture/formulation element. Significant experience with projects from preclinical to full scale GMP manufacture is sought as is demonstrable expertise in supply chain management. Prior experience of running projects outsourced to CROs/CRM or other third parties would be most helpful and knowledge of ICH, EU-GMP and US-GMP relative to biologicals is essential and commitment to keeping up to date with requirements via regular training.