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Job Details

Director CMC, Program Lead - Biotech

Company: Barrington James Clinical
Location: Europe
Reference: CRBG - CMCLEAD2
Closing Date: 28 Jun 18
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

To Lead CMC operational deliverables according to strategy for their biologics product portfolio.

Requirements:

Responsibilities: 

  • Lead CMC development project teams
  • Accountable for driving and delivering the CMC strategy and operational activities
  • Responsible for setting the quality target product profile and agree it with the development team
  • Provide integrated CMC plans with full transparency of timelines, costs, risk analysis and risk mitigation
  • Prepare the budget and manage the program related costs within the target budget
  • Ensure internal and external communication of the program and escalate critical issues to the respective governance bodies if needed
  • Review the CMC section of Regulatory dossiers and serve as interface with the regulatory group
  • Assist the technical experts with tracking the completion of required technical deliverables via dashboards and reporting on project metrics

Requirements:

  • Scientific University degree or equivalent
  • Experience in Pharmaceutical Industry or Biotechnology
  • Direct CMC experience with biotech products
  • Experience in developing and launching commercially viable pharmaceuticals or combination drugs
  • Expertise in project management and risk assessment
  • Demonstrated ability to influence stakeholders without line authority
  • Advanced conflict management and negotiation skills
  • Ability to see the big picture
  • Excellent command of English; German and French would be an asset

Apply for this job: Director CMC, Program Lead - Biotech

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
RH6 7AF
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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