Senior Scientist MSAT

Lead cutting‑edge drug product processes and drive innovation in PFS manufacturing from tech transfer to validation.

Proclinical is seeking a Senior Scientist MSAT to join a dynamic team in Germany. This role focuses on leading and supporting technology transfers, scale‑up activities, and process validation for drug product manufacturing, with a strong emphasis on Pre‑Filled Syringes (PFS). You will act as a subject matter expert, driving innovation, operational excellence, and robust process implementation while collaborating closely with internal and external stakeholders.

Responsibilities

• Lead and optimize drug product manufacturing processes, focusing on PFS and full process chains such as thawing, formulation, filling, and assembly‑packaging.
• Drive technology transfer activities from development to clinical and commercial manufacturing, ensuring scalable and compliant processes.
• Develop and execute scale‑up strategies, conduct risk assessments, and design efficient process validation strategies.
• Author and review technical documentation, protocols, reports, and submissions, while providing scientific support during audits and client interactions.
• Troubleshoot manufacturing challenges, lead investigations, and contribute to continuous improvement initiatives.
• Support new product introductions by conducting risk assessments, defining process control strategies, and preparing process descriptions and Bills of Materials (BOMs).
• Contribute to technology development, including liquid and lyophilized vial filling, and serve as technical lead in drafting proposals for new clients.
• Develop filter validation strategies, review related protocols and reports, and ensure compliance with regulatory and EU GMP Annex 1 requirements.
• Engage hands‑on during tech transfer and manufacturing activities, sharing knowledge and building team capabilities.

Key Skills and Requirements

• Advanced degree (PhD or MS) in Biological Sciences, Engineering, or a related field.
• Experience managing complex cGMP drug product manufacturing or development projects.
• Expertise in drug product technologies, particularly PFS, and familiarity with liquid and lyophilized vial filling processes.
• Solid knowledge of regulatory requirements, pharmaceutical standards, and validation processes.
• Strong analytical and problem‑solving skills with a data‑driven approach to troubleshooting.
• Excellent communication skills for client interactions, audits, and cross‑functional collaboration.
• Hands‑on proactive mentality with the ability to work effectively on the shopfloor.
• Ability to transfer knowledge, contribute to team development, and support long‑term strategy building.
• Familiarity with project management tools and Minitab is a plus.