Head of CMC
The Head CMC is a distinct expert in CMC area (e.g. regulatory CMC aspects, process optimization, up-scaling, manufacturing and supply chain management), with broad overview on all different aspects along the value chain. They will be responsible for taking the lead compounds through phase 3 and commercial manufacturing.
- Establish, manage and lead the CMC development and supply for drug substances and drug products from pre-clinical through commercial. Main focus is on Phase 3.
- Ensure full compliance with all CMC specific regulatory and quality requirements (externally and internally) supported by internal and external experts and opinion leaders
- Effective managing (and hands-on) of external partners and outsourced activities: Establish, lead and drive supplier selection (for manufacturing, formulation, analysis, distribution, QP etc. services), qualification, negotiations, implementation and project controlling (member of joint steering committees, project leader function, sourcing responsibility).
- Lead CMC relevant interactions with regulatory bodies (FDA, EMA, MHRA etc.). Actively participate in preparation and attend regulatory meetings and prepare filings (domestic and international)
- Working with Quality Assurance, develop SOPs and guidelines related to the production, planning, materials, disposition and management etc.
- Direct/oversee contract manufacturing, testing, packaging and labeling and distribution operations for the company’s drug substances and drug products
- Develop production plans and budgets to support preclinical, clinical, and commercial development
- Review and approve master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations, as required.
- Manage all electronic archiving of relevant CMC data
- Line management of a small internal group in alignment with external partners to form effective CMC sub team.
- Core member of project team
Qualifications and Experience:
- BSc. /MSc. Or Ph.D. in a relevant discipline
- Minimum 10 years of experience in CMC, particularly drug product development, sterility and formulation experience.
- Regulatory CMC experience including leading negotiations with EMA and / or FDA
- Quality assurance know-how especially in terms of handling changes and deviations throughout the development process
- Excellence in project management. Personality with a “can do” mind-set and your willingness to take on accountability and responsibility to get a job done is high.
- Fluent in both written and spoken English
- Relevant working/residency permit or Swiss/EU-Citizenship required