Head of CMC

Reference Number: 895400-W
Type of placement: Permanent, Permanent
Location: Switzerland, North West

Introduction:

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.

 

Main Responsibilities:

  • 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

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