Manufacturing Scientist Global MS&T USP Full-time

Manufacturing Scientist Global MS&T USP

Mainz, Germany | Full Time | Job ID: 9381

The 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.