Lonza
Head Manufacturing for Lyophilized Vials in a Growth Project(m/w/x)
Full-timeOn-siteManagement
Stein (AR)
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LOLonza
Senior Global Technology Transfer Lead(m/w/x)
Stein (AR)
Full-timeOn-siteSenior
Nejo AI Summary
Overseeing process setup and scale-up for medicine manufacturing across 30+ global sites. Industry-leading expertise in aseptic protein drug product manufacturing highly desirable. Global coordination across 30+ manufacturing sites.
Requirements
- MSc or PhD in Pharmaceutical Sciences, Engineering, Chemistry, Biochemistry, Bioengineering, or related field
- Ability to translate scientific depth into strategic decision-making
- Industry-leading expertise in biotech/pharma/CDMO; drug product development, technology transfer, aseptic product manufacture of protein drug products, lyophilization process highly desirable and/or manufacturing experience in prefilled syringes
- Ability to influence platform strategy and drive innovation in complex operational environments
- Deep knowledge of GMP, regulatory expectations, and CMC requirements for late-stage and commercial biologics
- Capability in translating program objectives into robust operational manufacturing processes
- Excellent communication, stakeholder management, and supervisory skills; ability to influence senior/executive levels
- Strong command of risk management and scenario planning
- Exemplary planning and organizing skills, including project management, risk management, interpretation and communication of complex scientific data, technical writing skills
- Experience driving manufacturing strategy, resolving high-impact technical issues, and overseeing cross-site initiatives
- Excellent written and oral English communication skills
- German language skills (advantage)
Tasks
- Lead harmonization and standardization across sites
- Oversee process setup and scale-up
- Oversee GMP change management
- Oversee on-site technical support during execution
- Guide manufacturing strategy
- Ensure compliance with global standards
- Enable seamless transfer of complex projects
- Enable seamless implementation of complex projects
- Manage end-to-end commercial drug product transfers
- Act as global Subject Matter Expert for Tech Transfer
- Shape technical strategy
- Ensure global standard alignment
- Drive customer-centric excellence across sites
- Drive customer-centric excellence across product lifecycles
- Provide technical authority
- Serve as senior escalation point for technical challenges
- Provide tech transfer leadership for late-phase programs
- Provide tech transfer leadership for commercial programs
- Serve as primary technical contact for technology transfer topics
- Liaise with internal and customer project teams
- Define and monitor project scope
- Define and monitor project timing
- Define and monitor project progress
- Lead process setup and scale-up activities
- Lead implementation activities at GMP sites
- Provide on-site technical support during batch execution
- Manage new product introduction
- Manage process implementation documentation
- Develop process control strategy
- Prepare technical transfer documentation
- Prepare process validation documentation
- Review dossier modules for regulatory filing
- Drive GMP change management strategy
- Initiate and manage GMP change control
- Lead and support critical GMP deviations
- Implement corrective and preventive actions (CAPAs)
- Ensure compliance with GMP, HSE, and regulatory standards
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Benefits
Bonuses & Incentives
- Performance-based compensation programs
Career Advancement
- Agile career
Startup Environment
- Dynamic work culture
Informal Culture
- Collaborative environment
Purpose-Driven Work
- Inclusive and ethical workplace
Other Benefits
- Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza 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?
- CH12 Lonza AG
Head MSAT, Drug Product Stein(m/w/x)
Full-timeOn-siteSeniorStein (AR) - CH12 Lonza AG
Global MSAT Drug Product Qualification and Validation Lead(m/w/x)
Full-timeOn-siteSeniorStein (AR) - Lonza
MSAT Expert(m/w/x)
Full-timeOn-siteExperiencedStein (AR) - Lonza
Global MSAT Lyophilization Equipment and Process Lead(m/w/x)
Full-timeOn-siteSeniorStein (AR)
LOLonza
Senior Global Technology Transfer Lead(m/w/x)
Stein (AR)
Full-timeOn-siteSenior
Nejo AI Summary
Overseeing process setup and scale-up for medicine manufacturing across 30+ global sites. Industry-leading expertise in aseptic protein drug product manufacturing highly desirable. Global coordination across 30+ manufacturing sites.
Requirements
- MSc or PhD in Pharmaceutical Sciences, Engineering, Chemistry, Biochemistry, Bioengineering, or related field
- Ability to translate scientific depth into strategic decision-making
- Industry-leading expertise in biotech/pharma/CDMO; drug product development, technology transfer, aseptic product manufacture of protein drug products, lyophilization process highly desirable and/or manufacturing experience in prefilled syringes
- Ability to influence platform strategy and drive innovation in complex operational environments
- Deep knowledge of GMP, regulatory expectations, and CMC requirements for late-stage and commercial biologics
- Capability in translating program objectives into robust operational manufacturing processes
- Excellent communication, stakeholder management, and supervisory skills; ability to influence senior/executive levels
- Strong command of risk management and scenario planning
- Exemplary planning and organizing skills, including project management, risk management, interpretation and communication of complex scientific data, technical writing skills
- Experience driving manufacturing strategy, resolving high-impact technical issues, and overseeing cross-site initiatives
- Excellent written and oral English communication skills
- German language skills (advantage)
Tasks
- Lead harmonization and standardization across sites
- Oversee process setup and scale-up
- Oversee GMP change management
- Oversee on-site technical support during execution
- Guide manufacturing strategy
- Ensure compliance with global standards
- Enable seamless transfer of complex projects
- Enable seamless implementation of complex projects
- Manage end-to-end commercial drug product transfers
- Act as global Subject Matter Expert for Tech Transfer
- Shape technical strategy
- Ensure global standard alignment
- Drive customer-centric excellence across sites
- Drive customer-centric excellence across product lifecycles
- Provide technical authority
- Serve as senior escalation point for technical challenges
- Provide tech transfer leadership for late-phase programs
- Provide tech transfer leadership for commercial programs
- Serve as primary technical contact for technology transfer topics
- Liaise with internal and customer project teams
- Define and monitor project scope
- Define and monitor project timing
- Define and monitor project progress
- Lead process setup and scale-up activities
- Lead implementation activities at GMP sites
- Provide on-site technical support during batch execution
- Manage new product introduction
- Manage process implementation documentation
- Develop process control strategy
- Prepare technical transfer documentation
- Prepare process validation documentation
- Review dossier modules for regulatory filing
- Drive GMP change management strategy
- Initiate and manage GMP change control
- Lead and support critical GMP deviations
- Implement corrective and preventive actions (CAPAs)
- Ensure compliance with GMP, HSE, and regulatory standards
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Benefits
Bonuses & Incentives
- Performance-based compensation programs
Career Advancement
- Agile career
Startup Environment
- Dynamic work culture
Informal Culture
- Collaborative environment
Purpose-Driven Work
- Inclusive and ethical workplace
Other Benefits
- Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza 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
Lonza
Industry
Pharmaceuticals
Description
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
Not a perfect match?
- Lonza
Head Manufacturing for Lyophilized Vials in a Growth Project(m/w/x)
Full-timeOn-siteManagementStein (AR) - CH12 Lonza AG
Head MSAT, Drug Product Stein(m/w/x)
Full-timeOn-siteSeniorStein (AR) - CH12 Lonza AG
Global MSAT Drug Product Qualification and Validation Lead(m/w/x)
Full-timeOn-siteSeniorStein (AR) - Lonza
MSAT Expert(m/w/x)
Full-timeOn-siteExperiencedStein (AR) - Lonza
Global MSAT Lyophilization Equipment and Process Lead(m/w/x)
Full-timeOn-siteSeniorStein (AR)