SIEGFRIED DiNAMIQS AG
QA Specialist(m/w/x)
Full-timeOn-siteSenior
Schlieren
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SISIEGFRIED DiNAMIQS AG
Head of Manufacturing and MSAT(m/w/x)
Schlieren
Full-timeOn-siteManagement
Nejo AI Summary
Directing viral vector gene therapy manufacturing and MSAT operations at a specialized biopharma company, including upstream, downstream, and fill-finish. Proven leadership in GMP biopharma manufacturing and MSAT, ideally biologics or ATMPs, required. 5 weeks holidays, flexible working hours.
Requirements
- Advanced degree in Biotechnology, Bioprocess Engineering, Chemical Engineering, or related life sciences field
- Proven leadership experience in MSAT and manufacturing within a GMP-regulated biopharmaceutical environment, ideally in biologics or ATMPs space
- Strong expertise in upstream and downstream bioprocessing and related analytical methods, ideally using viral vectors
- Experience in sterile drug product manufacturing, including F&F operations
- Solid understanding of regulatory guidelines and experience supporting audits and inspections
- Experience with digital manufacturing systems (LIMS, eBR, SAP, automation platforms) would be desired
- Strong communication, problem-solving, and organizational skills with a hands-on, solution-oriented mindset
- High skills in written and spoken English; German would be a plus
Tasks
- Organize manufacturing and MSAT operations for timely and budget-friendly production
- Lead upstream, downstream, fill-finish, and support manufacturing to ensure safe and compliant delivery of products
- Develop the MSAT function, focusing on technology transfer, process validation, lifecycle management, and troubleshooting
- Drive process optimization and scale-up/scale-down activities
- Conduct process characterization and continued process verification
- Ensure compliance with GMP regulations and global regulatory requirements
- Support investigations, deviations, CAPAs, risk assessments, and root cause analyses in collaboration with QA, QC, and Regulatory Affairs
Work Experience
- approx. 1 - 4 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- LIMS
- eBR
- SAP
- automation platforms
Benefits
Flexible Working
- Flexible working hours
Learning & Development
- Learning opportunities
Purpose-Driven Work
- Impactful work
Informal Culture
- Creative freedom
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SIEGFRIED DiNAMIQS 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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SISIEGFRIED DiNAMIQS AG
Head of Manufacturing and MSAT(m/w/x)
Schlieren
Full-timeOn-siteManagement
Nejo AI Summary
Directing viral vector gene therapy manufacturing and MSAT operations at a specialized biopharma company, including upstream, downstream, and fill-finish. Proven leadership in GMP biopharma manufacturing and MSAT, ideally biologics or ATMPs, required. 5 weeks holidays, flexible working hours.
Requirements
- Advanced degree in Biotechnology, Bioprocess Engineering, Chemical Engineering, or related life sciences field
- Proven leadership experience in MSAT and manufacturing within a GMP-regulated biopharmaceutical environment, ideally in biologics or ATMPs space
- Strong expertise in upstream and downstream bioprocessing and related analytical methods, ideally using viral vectors
- Experience in sterile drug product manufacturing, including F&F operations
- Solid understanding of regulatory guidelines and experience supporting audits and inspections
- Experience with digital manufacturing systems (LIMS, eBR, SAP, automation platforms) would be desired
- Strong communication, problem-solving, and organizational skills with a hands-on, solution-oriented mindset
- High skills in written and spoken English; German would be a plus
Tasks
- Organize manufacturing and MSAT operations for timely and budget-friendly production
- Lead upstream, downstream, fill-finish, and support manufacturing to ensure safe and compliant delivery of products
- Develop the MSAT function, focusing on technology transfer, process validation, lifecycle management, and troubleshooting
- Drive process optimization and scale-up/scale-down activities
- Conduct process characterization and continued process verification
- Ensure compliance with GMP regulations and global regulatory requirements
- Support investigations, deviations, CAPAs, risk assessments, and root cause analyses in collaboration with QA, QC, and Regulatory Affairs
Work Experience
- approx. 1 - 4 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- LIMS
- eBR
- SAP
- automation platforms
Benefits
Flexible Working
- Flexible working hours
Learning & Development
- Learning opportunities
Purpose-Driven Work
- Impactful work
Informal Culture
- Creative freedom
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SIEGFRIED DiNAMIQS 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.
About the Company
SIEGFRIED DiNAMIQS AG
Industry
Pharmaceuticals
Description
The company specializes in the manufacturing of viral vector gene therapies and offers a range of services including process development and analytics.
Not a perfect match?
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Full-timeOn-siteSeniorZürich - Tecan
Site Manager & Head Operations(m/w/x)
Full-timeOn-siteManagementMännedorf, Nänikon - CHE-106.649.671 Fisher Clinical Services GmbH
Manufacturing Professional (USP or DSP)(m/w/x)
Full-timeOn-siteExperiencedLengnau