Proclinical Staffing

Director CMC Lead

Switzerland, Nyon
21 Apr 2021
05 May 2021
Chloe Yeung
Regulatory Affairs, CMC
Full Time
Contract Type
Experience Level
Experienced (non-manager)

A fantastic vacancy has become available for a Director CMC Lead in France. This pharmaceutical CMC job is an excellent opportunity to work for a global leader in the life sciences industry.

Job Responsibilities

  • Lead CMC development project team(s), accountable for driving and delivering the CMC strategy and operational activities to allow delivering high quality processes and products with appropriate validation and regulatory documentation for successful submission, and within agreed timelines and budget.
  • Represent CMC development within the Development Team providing integrated CMC plan with full transparency of timelines, costs, risk analysis and risk mitigation plan.
  • Ensures cross functional alignment and integration of interdependent activities via cross functional communication of plans and timeline with specific emphasis on critical path activities.
  • Ensure provision of a clearly defined manufacturing strategy for the assigned product including launch readiness and commercialization.
  • To ensure internal and external communication of the program status and escalate critical issues to the respective governance bodies.

Skills and Requirements

  • PhD in a life science domain
  • Minimum 10 years' experience in pharmaceutical development, biotechnology or related industry
  • Sound understanding of GMP practices
  • Strong leadership skills to work and manage international, cross-functional project teams
  • Expertise in project management and risk assessment
  • Demonstrated ability to influence stakeholders without line authority
  • Strong oral and written communication skills; strong interpersonal skills; demonstrated time management and decision making skills
  • Ability to foster collaboration, work effectively on cross-functional teams, and consistently deliver on-time
  • Experience with performing critical path analysis
  • Critical thinking and problem solving skills

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.