(Associate Director) Senior Scientist Manufacturing global MS&T

Gudejobs; Mainz; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Company bike

Job ticket

Deutschlandticket

Employer-funded pension

Childcare

Flexible hours

Zusammenfassung

BioNTech in Mainz is seeking a Scientist Linker Payload Manufacturing to provide scientific leadership for GMP manufacturing of linker-payloads and related chemicals. You will ensure robust processes, scale-up, and lifecycle management across late-stage clinical and commercial programs.

You will act as an interface with internal and external partners, drive investigations, document technical activities, and support regulatory submissions while collaborating with CDMOs/CMOs to maintain quality

Qualifikationen

• 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.
• Experience in GMP manufacturing of APIs/small molecule drug substances or chemical process development; ADC-related materials is a plus.
• Strong understanding of manufacturing processes including transfer, scale-up, lifecycle management, and troubleshooting.
• Experience with deviations, change controls, CAPAs, risk assessments and qualification/validation documentation under compliance frameworks.
• Familiarity with regulatory expectations for small molecule manufacturing including IND/IMPD/MAA submissions or equivalents.

Aufgaben

• Provide scientific and technical support for manufacture, transfer, optimization, and lifecycle management of linker-payload manufacturing processes.
• Act as SME and primary contact for process performance, changes, and troubleshooting.
• Support process scale-up, technology transfer and process validation readiness at sites.
• Drive investigations, root-cause analyses, deviations, CAPAs, risk assessments, and process improvement.
• Review and approve manufacturing instructions, validation docs, investigation reports, and transfer packages.

Kenntnisse

GMP manufacturing

Process chemistry

Scale-up expertise

Regulatory compliance

Quality investigations

Ausbildung

Master’s degree or PhD in Organic Chemistry/Process Chemistry/Chemical Engineering/Pharmaceutical Sciences

Tools

CAPA systems

Documentation management

Process validation

Jobbeschreibung

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

Inspired? Become part of #TeamBioNTech.

BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting‑edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encouragecreativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

BioNTech - As unique as you

www.biontech.com