Merck & Co., Inc., Rahway, NJ, USA
Quality Assurance Lead(m/w/x)
Full-timeOn-siteManagement
Köln
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Leading technology transfers and process validation for Pre-Filled Syringes (PFS) drug product manufacturing. 3+ years project leadership experience managing complex cGMP drug product projects required. High-responsibility role in an innovative environment.
Requirements
- Advanced degree (PhD or MS) in Biological Sciences, Engineering or related field
- 3+ years pharmaceutical industry experience (PhD)
- 5+ years pharmaceutical industry experience (MS)
- Over 3 years project leadership experience
- Managing complex cGMP Drug Product manufacturing or development projects
- Deep understanding of Drug Product technologies
- Familiarity with PFS, liquid and lyophilized vial filling
- Solid knowledge of regulatory requirements and pharmaceutical standards
- Strong experience with EU GMP Annex 1
- Strong experience with validation, risk assessments, process characterization
- Proven ability to lead complex cross-functional projects
- Involving multiple internal and external stakeholders
- Strong analytical and problem-solving skills
- Data-driven approach to troubleshooting and process improvement
- Excellent communication skills
- Ability to represent MSAT in client interactions, audits, and meetings
- Hands-on, proactive mentality
- Ability to work effectively on shopfloor
- Support real-time troubleshooting
- Ability to transfer knowledge effectively
- Contribute to team development
- Support long-term MSAT strategy building
- Experience with project management tools is an asset
- Experience with Minitab is an asset
Tasks
- Lead technology transfers and scale-up activities
- Support process validation for drug product manufacturing
- Focus on Pre-Filled Syringes (PFS) and full process chains
- Act as subject matter expert for drug product technologies
- Contribute to process and technology development
- Support operational excellence across the site
- Drive technology transfer from development to manufacturing
- Ensure robust, compliant, and scalable processes
- Develop and execute scale-up strategies
- Conduct risk assessments and process characterization
- Design efficient process validation strategies
- Author and review technical documentation
- Provide scientific support during audits and client interactions
- Troubleshoot manufacturing challenges
- Lead scientific investigations and root cause analysis
- Define CAPA and contribute to continuous improvement
- Support new product introductions
- Lead risk assessments and define process control strategy
- Prepare process descriptions and instructions
- Create Bills of Materials (BOMs)
- Contribute to technology development
- Serve as technical lead in proposal drafting
- Develop filter validation strategies
- Review related protocols and reports
- Ensure alignment with regulatory and EU GMP Annex 1 requirements
- Demonstrate hands-on engagement during tech transfer
- Share knowledge and build team capabilities
Work Experience
- 3 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- cGMP Drug Product manufacturing
- Drug Product technologies
- PFS
- liquid and lyophilized vial filling
- EU GMP Annex 1
- validation
- risk assessments
- process characterization
- project management tools
- Minitab
Benefits
Competitive Pay
- Market-competitive salary and benefits package
Career Advancement
- Stability and career opportunities
Purpose-Driven Work
- Meaningful impact on global healthcare
- High-responsibility role
Startup Environment
- Innovative environment
Learning & Development
- Professional growth and development
- Training opportunities
- Development programs
Informal Culture
- Culture of collaboration and knowledge sharing
- Teamwork
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Terumo Europe 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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Leading technology transfers and process validation for Pre-Filled Syringes (PFS) drug product manufacturing. 3+ years project leadership experience managing complex cGMP drug product projects required. High-responsibility role in an innovative environment.
Requirements
- Advanced degree (PhD or MS) in Biological Sciences, Engineering or related field
- 3+ years pharmaceutical industry experience (PhD)
- 5+ years pharmaceutical industry experience (MS)
- Over 3 years project leadership experience
- Managing complex cGMP Drug Product manufacturing or development projects
- Deep understanding of Drug Product technologies
- Familiarity with PFS, liquid and lyophilized vial filling
- Solid knowledge of regulatory requirements and pharmaceutical standards
- Strong experience with EU GMP Annex 1
- Strong experience with validation, risk assessments, process characterization
- Proven ability to lead complex cross-functional projects
- Involving multiple internal and external stakeholders
- Strong analytical and problem-solving skills
- Data-driven approach to troubleshooting and process improvement
- Excellent communication skills
- Ability to represent MSAT in client interactions, audits, and meetings
- Hands-on, proactive mentality
- Ability to work effectively on shopfloor
- Support real-time troubleshooting
- Ability to transfer knowledge effectively
- Contribute to team development
- Support long-term MSAT strategy building
- Experience with project management tools is an asset
- Experience with Minitab is an asset
Tasks
- Lead technology transfers and scale-up activities
- Support process validation for drug product manufacturing
- Focus on Pre-Filled Syringes (PFS) and full process chains
- Act as subject matter expert for drug product technologies
- Contribute to process and technology development
- Support operational excellence across the site
- Drive technology transfer from development to manufacturing
- Ensure robust, compliant, and scalable processes
- Develop and execute scale-up strategies
- Conduct risk assessments and process characterization
- Design efficient process validation strategies
- Author and review technical documentation
- Provide scientific support during audits and client interactions
- Troubleshoot manufacturing challenges
- Lead scientific investigations and root cause analysis
- Define CAPA and contribute to continuous improvement
- Support new product introductions
- Lead risk assessments and define process control strategy
- Prepare process descriptions and instructions
- Create Bills of Materials (BOMs)
- Contribute to technology development
- Serve as technical lead in proposal drafting
- Develop filter validation strategies
- Review related protocols and reports
- Ensure alignment with regulatory and EU GMP Annex 1 requirements
- Demonstrate hands-on engagement during tech transfer
- Share knowledge and build team capabilities
Work Experience
- 3 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- cGMP Drug Product manufacturing
- Drug Product technologies
- PFS
- liquid and lyophilized vial filling
- EU GMP Annex 1
- validation
- risk assessments
- process characterization
- project management tools
- Minitab
Benefits
Competitive Pay
- Market-competitive salary and benefits package
Career Advancement
- Stability and career opportunities
Purpose-Driven Work
- Meaningful impact on global healthcare
- High-responsibility role
Startup Environment
- Innovative environment
Learning & Development
- Professional growth and development
- Training opportunities
- Development programs
Informal Culture
- Culture of collaboration and knowledge sharing
- Teamwork
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Terumo Europe 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
Terumo Europe
Industry
Pharmaceuticals
Description
The company advances lifesaving medical technologies to benefit society and supports healthcare innovation.
Not a perfect match?
- Merck & Co., Inc., Rahway, NJ, USA
Quality Assurance Lead(m/w/x)
Full-timeOn-siteManagementKöln - MOMENTIVE PERFORMANCE MATERIALS GMBH
Sr Director Global Analytical & Process Technology(m/w/x)
Full-timeOn-siteManagementLeverkusen - Lonza Cologne GmbH
Quality Site Head(m/w/x)
Full-timeOn-siteSeniorKöln - Miltenyi Biotec
Leitung der Herstellung im Bereich Zell- und Gentherapie (CGT)(m/w/x)
Full-timeOn-siteSeniorBergisch Gladbach - SUSONITY
(Sr.) Medical Science Liaison Rare Disease / Tumour(m/w/x)
Full-time/Part-timeOn-siteSeniorMünchen, Köln, Gießen, Mainz, Frankfurt am Main, Göttingen, Erfurt, Leipzig, Dresden