Idorsia
Associate Director, Technical Project Leader Drug Product(m/w/x)
Full-timeOn-siteSenior
Basel
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IDIdorsia
Associate Director, Technical Project Leader Drug Substance(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Leading drug substance development for innovative small molecules at a biopharmaceutical company specializing in discovery. 5+ years pharmaceutical industry experience and drug substance scientific expertise required. Full lifecycle involvement from early phases to commercialization.
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
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
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GMP
- QbD
- DOE
- QRM
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Idorsia and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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IDIdorsia
Associate Director, Technical Project Leader Drug Substance(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Leading drug substance development for innovative small molecules at a biopharmaceutical company specializing in discovery. 5+ years pharmaceutical industry experience and drug substance scientific expertise required. Full lifecycle involvement from early phases to commercialization.
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
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
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GMP
- QbD
- DOE
- QRM
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Idorsia and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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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