CMC Project Manager

CMC Project Manager - Cambridge, UK, Permanent

CSG Talent are excited to be partnered with a global pharmaceutical business who are looking to bring in a brand new CMC Project Manager, based in the UK to drive their biopharma development programs.

You will be joining a company going through an exciting growth period as well as having the opportunity to join at the inception of a new site and team.

Your responsibilities will include:

• Manage and lead development of biologics from candidate selection through to clinical trials
• Support and lead BLA applications
• Technical authoring of IND and CTA applications
• Ensure cross collaboration across R&D departments, CMC and external partners as needed
• Oversight of program timelines and budgets to ensure project progress
• Leading scientific discussions related to cell-line development, process development etc
• Supporting Head of CMC with project related activities, translational science and creating a culture of scientific innovation
• Supporting site set up

To be successful in this role you will have:

• An advanced degree in relevant scientific subject (Masters or PhD preferred)
• Extensive hands-on experience developing biologics/antibody therapeutics
• Experience within oncology, immuno-oncology or cancer biology
• Full end to end experience supporting CMC programs/projects through to the clinic
• Previous experience inputting into INDs, CTAs & BLAs
• Excellent communication skills with individuals from ranges of backgrounds and the ability to manage multiple projects at once
• Project management qualification is preferred but not essential

This is a unique opportunity to blend a Technical Lead and Project Manager role and use your scientific expertise to deliver new, innovative drugs to patients and treat cancer.

To find out more about the CMC Project Manager position please apply or reach out to Hannah Mason at CSG.