Manufacturing Scientist Global MS&T USP

Job title:

Manufacturing Scientist Global MS&T USP

Company:

BioNTech

Job description

Mainz, Germany | full time | Job ID: 9381Manufacturing Scientist USP Global MS&TThe global Manufacturing Scientist USP (Upstream Processing) within the global MS&T (Manufacturing Science & Technology) Drug Substance team is a highly skilled expert in upstream processing technologies. This role is critical in supporting the manufacturing process owner by providing technical expertise in areas such as cell bank strategies and requirements, seed train approaches, production bioreactor technologies, and cell separation methods. You will contribute to the development, optimization, and lifecycle management of upstream processes across all stages of the manufacturing process. Close collaboration with CMC teams during product launch activities, including scaling procedures from laboratory models to full-scale manufacturing, is a key aspect of this role. Interaction with internal departments, contract manufacturers, and manufacturing network partners is essential to fulfill the responsibilities of this position.Responsibilities:

• Act as a subject matter expert (SME) for USP technologies, including cell bank strategies, seed train development, production bioreactors, and cell separation methods.
• Provide technical guidance for USP-related activities throughout the manufacturing lifecycle.
• Contribute to the development, optimization, and lifecycle management of upstream manufacturing processes.
• Support the transition of upstream processes into downstream operations during launch activities and tech transfers.
• Collaborate with CMC teams to implement procedures from scale-down models into at-scale manufacturing activities.
• Facilitate the successful transition of upstream manufacturing processes during product launches and technology transfers between commercial manufacturing sites.
• Ensure alignment of USP processes across sites and partners to maintain consistency and quality.
• Serve as the USP interface to internal departments such as Quality Assurance (QA), Engineering, Regulatory Affairs (RegAff), and CMC.
• Build strong relationships with external partners, including contract manufacturers and manufacturing network collaborators.
• Contribute to regulatory filing activities, including initial submissions and updates, by reviewing and aligning dossier content in the field of USP expertise.
• Ensure compliance with regulatory requirements and support audits as needed.
• Gather performance and capability data from manufacturing sites to identify opportunities for process harmonization and improvement.
• Responsible for cross-site investigations to identify and resolve process issues related to USP.

Qualifications:

• Advanced degree (MSc or PhD) in Biotechnology, Biochemistry, Chemical Engineering, or a related field.
• Extensive experience, 5 years in upstream processing technologies, including cell bank development, seed train strategies, bioreactor operations, and cell separation.
• Proven track record in manufacturing process development, optimization, and lifecycle management.
• Experience in tech transfer and launch activities within a biopharmaceutical or biotechnology environment.
• Deep technical knowledge of USP operations and equipment.
• Strong problem-solving and analytical skills, with the ability to lead investigations and implement solutions.
• Excellent communication and collaboration skills to work effectively across internal teams and external partners.
• Familiarity with regulatory requirements and filing processes.

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 12 PM to 4 PM CET).Job ID 9381 (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.Inspired? Become part of #TeamBioNTech.BioNTech, the storyAt 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, encourage creativity, 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. Apply today and become part of a mission that has the potential to change lives around the world.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

Expected salary

Location

Mainz am Rhein, Rheinland-Pfalz

Job date

Sat, 09 Aug 2025 01:09:17 GMT

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