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Global MSAT DS Senior Process Steward(m/w/x)
Process industrialization, gap assessments, and risk mitigation for biopharmaceutical product technical leads. 7+ years industrial experience in process development or manufacturing operations required; PhD advantageous. Work in a large biopharmaceutical organization with 100,000+ employees.
Requirements
- B.S. or M.S. degree in Chemical, Biochemical Engineering, or related discipline
- 7+ years of relevant industrial experience in process development, process engineering, or manufacturing operations
- PhD is advantageous
- Experience in collaborative, matrix team leadership and decision-making
- Demonstrated experience in process engineering, technical process development, process validation, or technology transfer
- Experience with E. coli & CHO processes
- Familiarity with pharmaceutical quality systems, industry guidelines, regulatory submission, health authority requirements, and platform-specific technology
- Advanced verbal and written communication skills
- Willingness to travel less than 10% as required
Tasks
- Support Product Technical Leads and Product Stewards in process industrialization
- Coordinate and execute process gap assessments
- Integrate identified risks into the risk log
- Develop mitigation strategies for risks
- Drive systematic process improvements based on insights
- Implement second source and change strategies
- Execute validated state support activities
- Respond to evolving conditions to ensure compliance
- Provide technical expertise for engineering runs
- Offer hands-on support for investigations and troubleshooting
- Lead non-product specific root cause analyses and investigations
- Leverage pilot plant team for scaled experimentation
- Support validation studies and process transfer to manufacturing sites
- Ensure implementation of network initiatives aligned with manufacturing plans
- Incorporate portfolio-wide aspects like material changes and Health Authority requirements
- Collaborate with global and site functions and leadership
- Translate business needs to digital strategy and product development teams
- Drive technical sustainability improvements for product, process, and technology
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
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Global MSAT DS Senior Process Steward(m/w/x)
Process industrialization, gap assessments, and risk mitigation for biopharmaceutical product technical leads. 7+ years industrial experience in process development or manufacturing operations required; PhD advantageous. Work in a large biopharmaceutical organization with 100,000+ employees.
Requirements
- B.S. or M.S. degree in Chemical, Biochemical Engineering, or related discipline
- 7+ years of relevant industrial experience in process development, process engineering, or manufacturing operations
- PhD is advantageous
- Experience in collaborative, matrix team leadership and decision-making
- Demonstrated experience in process engineering, technical process development, process validation, or technology transfer
- Experience with E. coli & CHO processes
- Familiarity with pharmaceutical quality systems, industry guidelines, regulatory submission, health authority requirements, and platform-specific technology
- Advanced verbal and written communication skills
- Willingness to travel less than 10% as required
Tasks
- Support Product Technical Leads and Product Stewards in process industrialization
- Coordinate and execute process gap assessments
- Integrate identified risks into the risk log
- Develop mitigation strategies for risks
- Drive systematic process improvements based on insights
- Implement second source and change strategies
- Execute validated state support activities
- Respond to evolving conditions to ensure compliance
- Provide technical expertise for engineering runs
- Offer hands-on support for investigations and troubleshooting
- Lead non-product specific root cause analyses and investigations
- Leverage pilot plant team for scaled experimentation
- Support validation studies and process transfer to manufacturing sites
- Ensure implementation of network initiatives aligned with manufacturing plans
- Incorporate portfolio-wide aspects like material changes and Health Authority requirements
- Collaborate with global and site functions and leadership
- Translate business needs to digital strategy and product development teams
- Drive technical sustainability improvements for product, process, and technology
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
About the Company
1201 F. Hoffmann-La Roche AG
Industry
Pharmaceuticals
Description
Roche is dedicated to advancing science and ensuring access to healthcare for everyone, with over 100,000 employees globally.
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