Boehringer Ingelheim
Senior Commercial Process Manager(m/w/x)
Full-timeOn-siteSenior
Ingelheim am Rhein, Biberach
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BIBioNTech SE
Senior Scientist Manufacturing(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Leading small molecule drug substance manufacturing for cancer and infectious disease therapies. GMP API manufacturing and process development expertise required. Flexible hours, vacation account, digital learning.
Requirements
- Master’s or PhD in Organic Chemistry, Process Chemistry, Chemical Engineering, or Pharmaceutical Sciences
- Strong GMP manufacturing experience of APIs/small molecule drug substances or chemical process development
- Experience with linker-payloads or ADC-related materials (strong plus)
- Solid understanding of chemical manufacturing processes
- Expertise in transfer optimization, scale-up, lifecycle management & troubleshooting within GMP
- Hands-on expertise with deviations, change controls, CAPAs, investigations, risk assessments
- Hands-on expertise with qualification/validation documentation under compliance frameworks
- Familiarity with regulatory expectations for small molecule manufacturing
- Contributions towards IND/IMPD/BLA/MAA submissions or equivalent filings globally
- Excellent stakeholder communication skills
- Structured problem-solving abilities
- Adaptability amidst fast-paced operational demands
- Fluent English communication skills (written and spoken)
- Chinese language skills (plus)
Tasks
- Provide scientific and technical leadership for small molecule drug substance manufacturing
- Focus on manufacturing processes, process understanding, and process robustness
- Manage scale-up, troubleshooting, and lifecycle management for clinical and commercial programs
- Act as a key interface between internal technical functions and external manufacturing partners
- Ensure processes are transferred, executed, and continuously improved in a compliant manner
- Maintain technical oversight of manufacturing activities
- Support process-related investigations and changes
- Contribute to robust supply for complex pharmaceutical products
- Provide scientific and technical support for linker-payload manufacturing processes
- Act as a process-focused subject matter expert
- Maintain deep technical understanding of manufacturing processes
- Serve as a key contact for process performance, changes, and operational troubleshooting
- Support process scale-up, technology transfer, and process validation readiness
- Drive manufacturing investigations, root-cause analyses, and deviations
- Support change controls, CAPAs, risk assessments, and process improvement measures
- Review, generate, and approve technical documentation
- Create manufacturing instructions, validation/qualification documents, and investigation reports
- Prepare process transfer packages and regulatory support documentation
- Collaborate with internal stakeholders like Technical Development/CMC teams
- Work with external CDMOs/CMOs to ensure seamless communication and alignment
- Contribute to harmonization of processes across sites
- Monitor performance using KPIs and risk management tools
- Drive continuous improvement initiatives
- Provide input to regulatory submissions and health authority responses
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Fluent
- Chinese – Basic
Benefits
Flexible Working
- Flexible hours
More Vacation Days
- Vacation account
Learning & Development
- Digital Learning
- LinkedIn Learning
Career Advancement
- Performance and talent development
- Leadership development
Other Benefits
- Apprenticeships
- Support for your full potential
Startup Environment
- Voice at the table
Informal Culture
- Culture on an equal footing
Purpose-Driven Work
- Opportunities to shape and impact
Company Bike
- Company bike
Public Transport Subsidies
- Job ticket
- Deutschlandticket
Retirement Plans
- Employer-funded pension
Childcare
- Childcare
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE 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?
- BioNTech SE
Director Manufacturing Sciences & Technology(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Senior Manufacturing Manager Global MS&T(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Director Process Engineering(m/w/x)
Full-timeOn-siteSeniorMainz
BIBioNTech SE
Senior Scientist Manufacturing(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Leading small molecule drug substance manufacturing for cancer and infectious disease therapies. GMP API manufacturing and process development expertise required. Flexible hours, vacation account, digital learning.
Requirements
- Master’s or PhD in Organic Chemistry, Process Chemistry, Chemical Engineering, or Pharmaceutical Sciences
- Strong GMP manufacturing experience of APIs/small molecule drug substances or chemical process development
- Experience with linker-payloads or ADC-related materials (strong plus)
- Solid understanding of chemical manufacturing processes
- Expertise in transfer optimization, scale-up, lifecycle management & troubleshooting within GMP
- Hands-on expertise with deviations, change controls, CAPAs, investigations, risk assessments
- Hands-on expertise with qualification/validation documentation under compliance frameworks
- Familiarity with regulatory expectations for small molecule manufacturing
- Contributions towards IND/IMPD/BLA/MAA submissions or equivalent filings globally
- Excellent stakeholder communication skills
- Structured problem-solving abilities
- Adaptability amidst fast-paced operational demands
- Fluent English communication skills (written and spoken)
- Chinese language skills (plus)
Tasks
- Provide scientific and technical leadership for small molecule drug substance manufacturing
- Focus on manufacturing processes, process understanding, and process robustness
- Manage scale-up, troubleshooting, and lifecycle management for clinical and commercial programs
- Act as a key interface between internal technical functions and external manufacturing partners
- Ensure processes are transferred, executed, and continuously improved in a compliant manner
- Maintain technical oversight of manufacturing activities
- Support process-related investigations and changes
- Contribute to robust supply for complex pharmaceutical products
- Provide scientific and technical support for linker-payload manufacturing processes
- Act as a process-focused subject matter expert
- Maintain deep technical understanding of manufacturing processes
- Serve as a key contact for process performance, changes, and operational troubleshooting
- Support process scale-up, technology transfer, and process validation readiness
- Drive manufacturing investigations, root-cause analyses, and deviations
- Support change controls, CAPAs, risk assessments, and process improvement measures
- Review, generate, and approve technical documentation
- Create manufacturing instructions, validation/qualification documents, and investigation reports
- Prepare process transfer packages and regulatory support documentation
- Collaborate with internal stakeholders like Technical Development/CMC teams
- Work with external CDMOs/CMOs to ensure seamless communication and alignment
- Contribute to harmonization of processes across sites
- Monitor performance using KPIs and risk management tools
- Drive continuous improvement initiatives
- Provide input to regulatory submissions and health authority responses
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Fluent
- Chinese – Basic
Benefits
Flexible Working
- Flexible hours
More Vacation Days
- Vacation account
Learning & Development
- Digital Learning
- LinkedIn Learning
Career Advancement
- Performance and talent development
- Leadership development
Other Benefits
- Apprenticeships
- Support for your full potential
Startup Environment
- Voice at the table
Informal Culture
- Culture on an equal footing
Purpose-Driven Work
- Opportunities to shape and impact
Company Bike
- Company bike
Public Transport Subsidies
- Job ticket
- Deutschlandticket
Retirement Plans
- Employer-funded pension
Childcare
- Childcare
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE 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
BioNTech SE
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Not a perfect match?
- Boehringer Ingelheim
Senior Commercial Process Manager(m/w/x)
Full-timeOn-siteSeniorIngelheim am Rhein, Biberach - BioNTech SE
Director Manufacturing Sciences & Technology(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Senior Manufacturing Manager Global MS&T(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Director Process Engineering(m/w/x)
Full-timeOn-siteSeniorMainz