Senior Scientist Manufacturing global MS&T

Responsibilities

• Provide scientific and technical leadership for the manufacture, transfer, and lifecycle management of linker-payload and small molecule drug substance processes.
• Act as a subject matter expert for manufacturing processes, providing troubleshooting and operational support across external manufacturing networks.
• Support process scale-up, technology transfer, and process validation readiness at manufacturing sites.
• Drive manufacturing investigations, including root-cause analyses, deviations, change controls, CAPAs, and risk assessments.
• Review and approve technical documentation such as manufacturing instructions, validation documents, and investigation reports.
• Collaborate with internal CMC teams and external CDMOs/CMOs to ensure seamless process execution and alignment.
• Contribute to regulatory submissions and health authority responses related to manufacturing processes.

Requirements

• Master’s degree or PhD in Organic Chemistry, Process Chemistry, Chemical Engineering, or Pharmaceutical Sciences.
• 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.
• Hands-on expertise in managing deviations, change controls, CAPAs, and investigations within a compliance framework.
• Solid understanding of chemical manufacturing processes, including scale-up and lifecycle management.
• Fluent English communication skills (written and spoken).

Preferred Qualifications

• Knowledge of linker-payloads or ADC-related materials.
• Familiarity with regulatory expectations for small molecule manufacturing (IND/IMPD/BLA/MAA).
• Chinese language skills.

Benefits

• Flexible working hours and vacation accounts.
• Professional growth through digital learning, leadership development, and LinkedIn Learning.
• Health and lifestyle support including a company bike and job ticket (Deutschlandticket).
• Employer-funded pension and childcare support.

About the Company

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. We focus on addressing high medical needs, such as cancer and infectious diseases, through innovation and a commitment to improving global health.