Roche
Global MSAT Senior Product & Process Steward(m/w/x)
Full-timeOn-siteSenior
Basel
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DS validation and MSAT project leadership for rare disease drug substance manufacturing. Expertise in CMC development and regulatory guidelines required. Work/life balance, professional growth opportunities.
Requirements
- University education in Chemistry, Biology, Biotechnology, Pharmacy or similar
- Scientific and technical background of CMC development and manufacturing of Drug Substance
- Expertise in drug substance manufacturing
- Experience in cross-functional teams, multitasking, prioritization, and decision making
- Experience with regulatory guidelines, authorities communication, and file documentation
- English fluency
Tasks
- Own DS validation for Sobi products
- Lead MSAT projects for manufacturing and cost improvement
- Participate in manufacturing process changes and deviations
- Conduct risk assessments and CAPAs
- Issue, review, and approve internal and external SOPs
- Supervise technical studies, qualifications, and validations
- Write and review APR/PQR sections
- Contribute to registration files, variations, and market expansion
- Evaluate new DS contract manufacturers
- Develop supply and quality agreements
- Lead product transfer and scale-up activities
- Oversee DS process validations at external manufacturers
- Stay informed about biopharmaceutical manufacturing advancements
- Introduce new technologies for process innovation and improvement
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Fluent
Benefits
Family Support
- Work/life balance
Informal Culture
- Collaborative and team-oriented environment
Career Advancement
- Professional growth opportunities
Other Benefits
- Diversity and Inclusion
- Competitive benefits package
Purpose-Driven Work
- Positive impact for rare disease patients
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sobi 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.
Not a perfect match?
- F. Hoffmann-La Roche AG
Global MSAT Drug Substance Technology Deployment Steward(m/w/x)
Full-timeOn-siteSeniorBasel - Roche
Global MSAT Senior Analytical Steward(m/w/x)
Full-timeOn-siteSeniorBasel - Novartis Pharma AG
Head of Drug Substance Project Leadership(m/w/x)
Full-timeOn-siteManagementBasel - 1201 F. Hoffmann-La Roche AG
Global MSAT DS Senior Process Steward(m/w/x)
Full-timeOn-siteSeniorBasel
DS validation and MSAT project leadership for rare disease drug substance manufacturing. Expertise in CMC development and regulatory guidelines required. Work/life balance, professional growth opportunities.
Requirements
- University education in Chemistry, Biology, Biotechnology, Pharmacy or similar
- Scientific and technical background of CMC development and manufacturing of Drug Substance
- Expertise in drug substance manufacturing
- Experience in cross-functional teams, multitasking, prioritization, and decision making
- Experience with regulatory guidelines, authorities communication, and file documentation
- English fluency
Tasks
- Own DS validation for Sobi products
- Lead MSAT projects for manufacturing and cost improvement
- Participate in manufacturing process changes and deviations
- Conduct risk assessments and CAPAs
- Issue, review, and approve internal and external SOPs
- Supervise technical studies, qualifications, and validations
- Write and review APR/PQR sections
- Contribute to registration files, variations, and market expansion
- Evaluate new DS contract manufacturers
- Develop supply and quality agreements
- Lead product transfer and scale-up activities
- Oversee DS process validations at external manufacturers
- Stay informed about biopharmaceutical manufacturing advancements
- Introduce new technologies for process innovation and improvement
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Fluent
Benefits
Family Support
- Work/life balance
Informal Culture
- Collaborative and team-oriented environment
Career Advancement
- Professional growth opportunities
Other Benefits
- Diversity and Inclusion
- Competitive benefits package
Purpose-Driven Work
- Positive impact for rare disease patients
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sobi 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
Sobi
Industry
Pharmaceuticals
Description
The company is a specialized biopharmaceutical company dedicated to rare diseases and committed to developing innovative therapies.
Not a perfect match?
- Roche
Global MSAT Senior Product & Process Steward(m/w/x)
Full-timeOn-siteSeniorBasel - F. Hoffmann-La Roche AG
Global MSAT Drug Substance Technology Deployment Steward(m/w/x)
Full-timeOn-siteSeniorBasel - Roche
Global MSAT Senior Analytical Steward(m/w/x)
Full-timeOn-siteSeniorBasel - Novartis Pharma AG
Head of Drug Substance Project Leadership(m/w/x)
Full-timeOn-siteManagementBasel - 1201 F. Hoffmann-La Roche AG
Global MSAT DS Senior Process Steward(m/w/x)
Full-timeOn-siteSeniorBasel