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121201 F. Hoffmann-La Roche AG

External Collaboration Expert - Analytical Development(m/w/x)

Basel
Full-timeOn-siteManagement

Developing cGMP-compliant testing processes and leading outsourcing strategy for Contract Lab Organizations in pharma. 10 years in pharmaceutical industry, 5 years in leadership, and substantial external partner experience required. Coordination with global cross-functional partners.

Requirements

  • PhD or Master's degree in chemistry
  • Bachelor’s degree with relevant experience
  • At least 10 years in pharmaceutical industry
  • Minimum 5 years in leadership position
  • Substantial experience with external partners
  • Experience in cGMP environment
  • Solid understanding of analytical chemistry
  • Experience with HPLC, GC, dissolution
  • Excellent knowledge of cGMP regulations
  • Proven experience with GMP inspections
  • Strong negotiation skills
  • Ability to build collaborative relationships
  • Comfortable with frequent changes
  • Ability to manage parallel activities
  • Solid project management skills
  • Systems-thinking approach
  • Continuous improvement mindset

Tasks

  • Lead the analytical outsourcing strategy for testing.
  • Guide PTDC-A professionals in external testing.
  • Coordinate with cross-functional partners on outsourcing.
  • Develop cGMP-compliant testing processes and support audits.
  • Define and monitor KPIs for Contract Lab Organizations.
  • Identify new externalization opportunities and suitable CLOs.
  • Promote continuous improvement and lean leadership principles.
  • Contribute to strategic goal setting and onboarding.

Work Experience

  • 10 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • HPLC
  • GC
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