Roche
Global MSAT Senior Product & Process Steward(m/w/x)
Full-timeOn-siteSenior
Basel
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NONovartis Pharma Schweizerhalle AG
.Product Steward(m/w/x)
Muttenz
Full-timeOn-siteExperienced
Nejo AI Summary
Ensuring end-to-end process knowledge for pharmaceutical manufacturing, using statistical data trending for continuous improvement. Master’s degree in Chemical Engineering or related field required. On-site work, 5-person team.
Requirements
- Master’s degree in Chemical Engineering, Chemistry or related scientific field
- Minimum 3 years experience in drug substance manufacturing or process support
- Knowledge of Good Manufacturing Practice and regulatory requirements
- Solid understanding of manufacturing processes, process validation and change control
- Experience with data analysis, applied statistics, and interpretation of process data
- Proven ability to work across functions and collaborate with diverse teams
- Proficiency in German and English (written and spoken)
- Experience in oligonucleotide manufacturing or development
- Applied Statistics
- Change Control
- Data Analytics and Digital
- GDP Knowledge
- gmp knowledge
- HSE Knowledge
- Manufacturing Process
- Manufacturing Production
- Manufacturing Technologies
- Operational Excellence
- Process and Cleaning Validation
- Process Control
- Quality Compliance
- Regulatory Compliance
- Resilience and Risk Management
- Technical Leadership
- Technology Transfer
Tasks
- Drive pharmaceutical manufacturing process performance and reliability
- Ensure end-to-end process knowledge across the product lifecycle
- Monitor process performance using statistical data trending
- Analyze critical variables to ensure process compliance
- Maintain products in a validated state through process verification
- Lead root cause investigations and implement corrective actions
- Support preventive actions and continuous process improvement
- Evaluate product performance and identify risks
- Initiate and lead optimization projects
- Collaborate cross-functionally for effective knowledge sharing
- Assess technical changes and define validation scope
- Support regulatory and process compliance activities
- Provide technical expertise for new product launches
- Author supporting documentation for new product phases
- Support product transfers with appropriate documentation
- Assist receiving sites during product transfers
Work Experience
- 3 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- Good Manufacturing Practice
- Applied Statistics
- Data Analysis
- Process Validation
- Change Control
- Oligonucleotide Manufacturing
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharma Schweizerhalle AG 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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Full-timeOn-siteSeniorBasel
NONovartis Pharma Schweizerhalle AG
.Product Steward(m/w/x)
Muttenz
Full-timeOn-siteExperienced
Nejo AI Summary
Ensuring end-to-end process knowledge for pharmaceutical manufacturing, using statistical data trending for continuous improvement. Master’s degree in Chemical Engineering or related field required. On-site work, 5-person team.
Requirements
- Master’s degree in Chemical Engineering, Chemistry or related scientific field
- Minimum 3 years experience in drug substance manufacturing or process support
- Knowledge of Good Manufacturing Practice and regulatory requirements
- Solid understanding of manufacturing processes, process validation and change control
- Experience with data analysis, applied statistics, and interpretation of process data
- Proven ability to work across functions and collaborate with diverse teams
- Proficiency in German and English (written and spoken)
- Experience in oligonucleotide manufacturing or development
- Applied Statistics
- Change Control
- Data Analytics and Digital
- GDP Knowledge
- gmp knowledge
- HSE Knowledge
- Manufacturing Process
- Manufacturing Production
- Manufacturing Technologies
- Operational Excellence
- Process and Cleaning Validation
- Process Control
- Quality Compliance
- Regulatory Compliance
- Resilience and Risk Management
- Technical Leadership
- Technology Transfer
Tasks
- Drive pharmaceutical manufacturing process performance and reliability
- Ensure end-to-end process knowledge across the product lifecycle
- Monitor process performance using statistical data trending
- Analyze critical variables to ensure process compliance
- Maintain products in a validated state through process verification
- Lead root cause investigations and implement corrective actions
- Support preventive actions and continuous process improvement
- Evaluate product performance and identify risks
- Initiate and lead optimization projects
- Collaborate cross-functionally for effective knowledge sharing
- Assess technical changes and define validation scope
- Support regulatory and process compliance activities
- Provide technical expertise for new product launches
- Author supporting documentation for new product phases
- Support product transfers with appropriate documentation
- Assist receiving sites during product transfers
Work Experience
- 3 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- Good Manufacturing Practice
- Applied Statistics
- Data Analysis
- Process Validation
- Change Control
- Oligonucleotide Manufacturing
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharma Schweizerhalle AG 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
Novartis Pharma Schweizerhalle AG
Industry
Pharmaceuticals
Description
The company is committed to helping people with disease and their families through innovative science and a supportive community.
Not a perfect match?
- Roche
Global MSAT Senior Product & Process Steward(m/w/x)
Full-timeOn-siteSeniorBasel - 1201 F. Hoffmann-La Roche AG
Senior DP (Drug Product) Product Steward - Global MSAT(m/w/x)
Full-timeOn-siteSeniorBasel - Roche
GMP Prozess Experte kommerzielle Pharmaproduktion(m/w/x)
Full-timeOn-siteExperiencedKaiseraugst - 1201 F. Hoffmann-La Roche AG
Global MSAT DS Senior Process Steward(m/w/x)
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Full-timeOn-siteSeniorBasel