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ID
Idorsia
8d ago

Associate Director, Technical Project Leader Drug Substance(m/w/x)

Basel
Full-timeOn-siteSenior

Description

You will drive the technical evolution of innovative medicines by leading drug substance development and manufacturing from early clinical phases through to successful commercial launch.

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Requirements

  • Degree in Chemistry, Chemical Engineering, or equivalent
  • Minimum 5 years pharmaceutical industry experience
  • Minimum 2 years interdisciplinary team leadership
  • Scientific expertise in Drug Substance development
  • Experience in drug substance regulatory strategies
  • Profound knowledge of GMP and QC
  • Profound knowledge in QbD, DOE, QRM
  • Ability to coordinate technical manufacturing activities
  • Excellent interpersonal and adaptation skills
  • Excellent oral and written English

Education

Master's degree
OR
Doctoral / PhD

Work Experience

5 years

Tasks

  • Lead drug substance development from early phases to commercialization
  • Manage production of drug substances for clinical and market supplies
  • Oversee manufacturing and scale-up activities for active pharmaceutical ingredients
  • Direct technical transfers and define critical process parameters
  • Plan and administer technical activities for drug validation
  • Coordinate with external partners to ensure cost-efficient scientific quality
  • Collaborate with drug product leaders on physico-chemical requirements
  • Develop and execute risk mitigation plans for supplies
  • Ensure compliance with evolving global regulatory guidelines
  • Perform nitrosamine risk assessments and other regulatory initiatives
  • Assume API safety project leadership responsibilities as required

Tools & Technologies

GMPQbDDOEQRM

Languages

EnglishBusiness Fluent

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