(Associate Director) Senior Scientist Manufacturing global MS&T

Mainz, Germany   |   full time   |   Job ID: 11298 

 

 

About the Role

 

As Scientist Linker Payload Manufacturing, you will provide scientific and technical leadership for the manufacture of small molecule drug substances, linker-payloads, and related chemical entities in a highly regulated GMP environment. Your focus will be on manufacturing processes, process understanding, process robustness, scale-up, troubleshooting, and lifecycle management across late-stage clinical and commercial programs.

In this role, you will act as a key interface between internal technical functions and external manufacturing partners, ensuring that processes are transferred, executed, and continuously improved in a compliant, reliable, and scalable manner. You will help maintain technical oversight of manufacturing activities, support process-related investigations and changes, and contribute to robust supply for complex pharmaceutical products.

 

Your Contribution

 

• Provide scientific and technical support for the manufacture, transfer, optimization, and lifecycle management of linker-payload manufacturing processes across external manufacturing networks
• Act as a process-focused subject matter expert, maintaining deep technical understanding of manufacturing processes and serving as a key contact for process performance, process changes, and operational troubleshooting
• Support process scale-up, technology transfer, process validation readiness, and implementation at manufacturing sites
• Drive and support manufacturing investigations, root-cause analyses, deviations, change controls, CAPAs, risk assessments, and process improvement measures
• Review, generate, and approve technical documentation such as manufacturing instructions, validation/qualification documents, investigation reports, process transfer packages, and regulatory support documentation
• Collaborate closely with internal stakeholders such as Technical Development/CMC teams as well as external CDMOs/CMOs to ensure seamless communication and alignment
• Contribute to harmonization of processes across sites while monitoring performance using KPIs/risk management tools to drive continuous improvement initiatives
• Provide input to regulatory submissions and health authority responses related to manufacturing processes

 

A Good Match

 

• • Master’s degree or PhD in Organic Chemistry, Process Chemistry, Chemical Engineering or Pharmaceutical Sciences with 5+ years of relevant experience in a regulated pharmaceutical or biotech environment
  • Strong experience in GMP manufacturing of APIs/small molecule drug substances or chemical process development; experience with linker-payloads or ADC-related materials is a strong plus
  • Solid understanding of chemical manufacturing processes including transfer optimization scale-up lifecycle management & troubleshooting within GMP settings
  • Hands-on expertise in dealing with deviations change controls CAPAs investigations risk assessments & qualification/validation documentation under compliance frameworks
  • Familiarity with regulatory expectations for small molecule manufacturing including contributions towards IND/IMPD/BLA/MAA submissions or equivalent filings globally
  • Excellent stakeholder communication skills coupled alongside structured problem-solving abilities adaptable even amidst fast-paced operational demands
  • Fluent English communication skills, both written and spoken; Chinese language skills are a plus 

 

 

Your Benefits:

 

It's our priority to support you:

• Your flexibility: flexible hours | vacation account  
• Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle: Company bike
• Your mobility: Job ticket | Deutschlandticket 
• Your life phases: Employer-funded pension | Childcare 

 

 

Apply now - We look forward to your application!

 

Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).

 

Job ID 11298 (please always specify if you have any questions)   

 

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applica