Associate Director 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
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- 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)
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