Senior CMC Expert (m/f)

Job description

Would you like to join a pharmaceutical company where you can yield your skills, your knowledge in scientific/ technical line functions and your leadership experience?

If so, take the chance to become a Senior CMC Expert in Biberach/ Germany.

Job Profile

· As a Senior CMC Expert you take over the leadership in driving cross-functional CMC development strategy for key therapeutical biological development projects
· You will support CMC teams for biological products critical to BI
· You drive crossfunctional scientific/ technical expertise in biological development and sound knowledge of global regulatory guidelines to proactively drive crossfunctional CMC content, in close collaboration with CMC project management and individual line functions (Bioprocess & Pharmaceutical Development)
· Taking into account current & evolving regulatory requirements you have to ensure that content of CMC workpackages and documentation are phase appropriate, meet state of the art regulatory expectations and enable smooth approval of regulatory submissions
· You are responsible to identify critical CMC/CMC regulatory issues, drive strategies and implementation for their resolution
· You promote CMC issues and represent CMC interests of development, production and quality in authority meetings
· You assess agency requirements and drive development of science based approach/ line of argumentation to obtain buy-in of regulatory agencies, together with appropriate line function SMEs and CMC project leader
· The close collaboration with CMC Regulatory Affairs (Corporate) and the varification of alignment regarding regulatory questions and strategies in consultancy team is part of your business

Requirements

· You hold a Ph.D. or Master's degree in Chemistry, Biopharmaceuticals, Biochemistry or Biology
· You have experience for 3 or more years in scientific/ technical line functions (e.g. upstream/ downstream/ analytical or drug product development, drug/device combination product development) in a fully integrated biopharmaceutical organization
· You have leadership experience for 2 or more years in one or more scientific/ technical line functions (e.g. upstream/ downstream/ analytical or drug product development, drug/device combination product development, etc)
· You are experienced in global regulatory filings for biologics (IND/IMPD, BLA/MAA)
· Your understanding of natural and medical sciences is ideally combined with regulatory affairs
· Your fluency in English both in writing and speaking, as well as your excellent communication and negotiation skills will enable you to act in an international working environment