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Associate Director, Technical Project Leader Drug Substance(m/w/x)
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.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
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
Languages
English – Business Fluent
- IdorsiaFull-timeOn-siteSeniorBasel
- Novartis Pharma AG
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Associate Director, Technical Project Leader Drug Substance(m/w/x)
The AI Job Search Engine
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.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
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
Languages
English – Business Fluent
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.
- Idorsia
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