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121201 F. Hoffmann-La Roche AG

Section Lead & Center of Excellence (CoE) Strategy Realization(m/w/x)

Basel
Full-timeOn-siteManagement

Leading a team of four associate scientists in formulation and process development for complex SM parenterals. Direct experience with regulatory CMC source and submission documents required. Strategic role within a global healthcare company's Center of Excellence.

Requirements

  • Deep scientific expertise in formulation and process development for parenteral dosage forms
  • Proven ability to lead and inspire a scientific team
  • Direct experience in writing and reviewing regulatory CMC source and submission documents
  • Problem-solving mindset and ability to manage multiple parallel projects
  • Deep expertise in analytical methods for characterizing liquid formulations

Tasks

  • Provide focus on formulation and process development strategies
  • Deliver the complex SM parenterals portfolio
  • Act as the Pharmaceutical Development SPOC for research organizations
  • Conduct CMC risk assessments and develop mitigations for portfolio molecules
  • Lead a team of four associate scientists
  • Foster a collaborative and high-performing team environment
  • Manage lab equipment capabilities for SM DP parenterals
  • Ensure End-to-End connectivity with cross-functional partners
  • Lead the team's operational focus and strategic direction
  • Ensure adherence to stringent quality standards in laboratory work
  • Maintain data integrity for non-GMP data in collaboration with partner functions

Work Experience

  • 6 years

Education

  • Master's degree

Languages

  • EnglishBusiness Fluent
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