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ID
Idorsia
8d ago

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

Basel
Full-timeOn-siteSenior

Description

In this role, you will drive the technical journey of oral solid medicines from early development to market, ensuring scientific quality while leading external partnerships and CMC strategy.

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Requirements

  • Pharmacist, equivalent with PhD, or pharmaceutical experience
  • Leadership of interdisciplinary drug product teams
  • Expertise in small molecule formulation development
  • Expertise in oral solid dosage forms
  • Knowledge of GMP and pharmaceutical processes
  • Knowledge in QbD, DOE and QRM
  • Ability to coordinate technical development activities
  • Excellent interpersonal and adaptability skills
  • Excellent oral and written English

Education

Vocational certification
OR
Doctoral / PhD

Tasks

  • Lead technical development of oral solid dosage forms
  • Manage formulation development and production scale-up
  • Oversee drug product analysis and manufacturing
  • Coordinate clinical and market form production
  • Administer technical activities from development to commercial supply
  • Direct collaborations with external development partners
  • Ensure cost efficiency and scientific quality
  • Support the overall CMC strategy execution
  • Serve as Subject Matter Expert for manufacturing technologies
  • Secure timely supplies for development projects
  • Maintain compliance with all regulatory guidelines

Tools & Technologies

Lipid Based FormulationsAmorphous Solid DispersionsGMPQbDDOEQRM

Languages

EnglishBusiness Fluent

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