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Associate Director, Technical Project Leader Drug Product(m/w/x)
Leading technical development of oral solid dosage forms, managing formulation and production scale-up for small molecule biopharmaceuticals. Leadership of interdisciplinary drug product teams and small molecule formulation expertise essential. Full project lifecycle involvement in small molecule biopharmaceutical development.
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
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
Education
- Vocational certification
Languages
- English – Business Fluent
Tools & Technologies
- Lipid Based Formulations
- Amorphous Solid Dispersions
- GMP
- QbD
- DOE
- QRM
Not a perfect match?
- IdorsiaFull-timeOn-siteSeniorBasel
- Novartis Pharma AG
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Associate Director, Technical Project Leader Drug Product(m/w/x)
Leading technical development of oral solid dosage forms, managing formulation and production scale-up for small molecule biopharmaceuticals. Leadership of interdisciplinary drug product teams and small molecule formulation expertise essential. Full project lifecycle involvement in small molecule biopharmaceutical development.
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
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
Education
- Vocational certification
Languages
- English – Business Fluent
Tools & Technologies
- Lipid Based Formulations
- Amorphous Solid Dispersions
- GMP
- QbD
- DOE
- QRM
About the Company
Idorsia
Industry
Pharmaceuticals
Description
The company is a high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules.
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