(Associate Director) Senior Scientist Manufacturing global MS&T

Job description

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 applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.