Takeda Manufacturing Austria AG
Associate Director, API Process Engineering(m/w/x)
Full-timeOn-siteManagement
Zürich, Neuenburg, Oranienburg
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CSCSL Vifor
Director, CMC Strategy and Tech Transfer(m/w/x)
Zürich
Full-timeOn-siteSenior
Nejo AI Summary
Defining end-to-end CMC strategy and overseeing tech transfer for iron deficiency and nephrology therapies. Advanced degree in a science field required, MBA a plus. Well-being support and global manufacturing network exposure.
Requirements
- Advanced degree (PhD, MSc, or equivalent) in Chemical Engineering, Biotechnology, Pharmacy, or related field
- MBA is a plus
- Strong experience in CMC strategy, technology transfer, and manufacturing
- Proven leadership in regulatory submissions and health authority interactions
- Extensive experience with CDMOs and global manufacturing networks
- Deep expertise in CMC development and lifecycle management
- Strong understanding of biologics and/or small molecule processes
- Expertise in GMP, validation, and regulatory requirements
- Strategic thinking with strong execution capability
- Excellent leadership and stakeholder management skills
- Strong business acumen and risk-based decision making
Tasks
- Define and drive end-to-end CMC strategy
- Align CMC plans with program strategy and timelines
- Lead CMC contributions to regulatory submissions
- Advise senior leadership on CMC risks and decisions
- Provide executive oversight of technology transfer
- Ensure robust transfer strategies and validation
- Oversee transfers to and from CDMOs and global sites
- Ensure readiness of receiving units
- Align Process Development, MS&T, and Manufacturing
- Guide process characterization and lifecycle management
- Drive manufacturing readiness for clinical and commercial supply
- Ensure compliance with global regulatory expectations
- Oversee preparation and review of CMC sections
- Represent CMC during health authority interactions
- Define external manufacturing and development strategy
- Select and oversee CDMOs
- Establish governance models for performance and quality
- Identify and mitigate key CMC risks
- Lead cross-functional decision-making for CMC challenges
- Ensure continuity of supply and inspection readiness
- Lead and develop a team of scientists and engineers
- Foster a culture of technical excellence and collaboration
- Influence cross-functional teams without direct authority
Work Experience
- 12 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Mental Health Support
- Well-being support
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Vifor 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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CSCSL Vifor
Director, CMC Strategy and Tech Transfer(m/w/x)
Zürich
Full-timeOn-siteSenior
Nejo AI Summary
Defining end-to-end CMC strategy and overseeing tech transfer for iron deficiency and nephrology therapies. Advanced degree in a science field required, MBA a plus. Well-being support and global manufacturing network exposure.
Requirements
- Advanced degree (PhD, MSc, or equivalent) in Chemical Engineering, Biotechnology, Pharmacy, or related field
- MBA is a plus
- Strong experience in CMC strategy, technology transfer, and manufacturing
- Proven leadership in regulatory submissions and health authority interactions
- Extensive experience with CDMOs and global manufacturing networks
- Deep expertise in CMC development and lifecycle management
- Strong understanding of biologics and/or small molecule processes
- Expertise in GMP, validation, and regulatory requirements
- Strategic thinking with strong execution capability
- Excellent leadership and stakeholder management skills
- Strong business acumen and risk-based decision making
Tasks
- Define and drive end-to-end CMC strategy
- Align CMC plans with program strategy and timelines
- Lead CMC contributions to regulatory submissions
- Advise senior leadership on CMC risks and decisions
- Provide executive oversight of technology transfer
- Ensure robust transfer strategies and validation
- Oversee transfers to and from CDMOs and global sites
- Ensure readiness of receiving units
- Align Process Development, MS&T, and Manufacturing
- Guide process characterization and lifecycle management
- Drive manufacturing readiness for clinical and commercial supply
- Ensure compliance with global regulatory expectations
- Oversee preparation and review of CMC sections
- Represent CMC during health authority interactions
- Define external manufacturing and development strategy
- Select and oversee CDMOs
- Establish governance models for performance and quality
- Identify and mitigate key CMC risks
- Lead cross-functional decision-making for CMC challenges
- Ensure continuity of supply and inspection readiness
- Lead and develop a team of scientists and engineers
- Foster a culture of technical excellence and collaboration
- Influence cross-functional teams without direct authority
Work Experience
- 12 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Mental Health Support
- Well-being support
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Vifor 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
CSL Vifor
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globaler Partner für pharmazeutische Produkte und innovative Therapien in der Eisenmangel- und Nephrologie.
Not a perfect match?
- Takeda Manufacturing Austria AG
Associate Director, API Process Engineering(m/w/x)
Full-timeOn-siteManagementZürich, Neuenburg, Oranienburg - Takeda Pharmaceuticals International AG
GRA CMC Director - Marketed Products Development Lead(m/w/x)
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Senior Director, Head of Translational Research Hematology & CVR(m/w/x)
Full-timeOn-siteManagementSchlieren - Takeda
Global Manufacturing Sciences BioProcess Lead (Sr. Manager)(m/w/x)
Full-timeOn-siteSeniorZürich - CSL Behring
Director, Sr. Global Regulatory Lead - Cardiorenal(m/w/x)
Full-timeOn-siteSeniorGlattbrugg