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:
1. Lead and optimize drug product manufacturing processes, focusing on PFS and full process chains such as thawing, formulation, filling, and assembly-packaging.
2. Drive technology transfer activities from development to clinical and commercial manufacturing, ensuring scalable and compliant processes.
3. Develop and execute scale-up strategies, conduct risk assessments, and design efficient process validation strategies.
4. Author and review technical documentation, protocols, reports, and submissions, while providing scientific support during audits and client interactions.
5. Troubleshoot manufacturing challenges, lead investigations, and contribute to continuous improvement initiatives.
6. Support new product introductions by conducting risk assessments, defining process control strategies, and preparing process descriptions and Bills of Materials (BOMs).
7. Contribute to technology development, including liquid and lyophilized vial filling, and serve as technical lead in drafting proposals for new clients.
8. Develop filter validation strategies, review related protocols and reports, and ensure compliance with regulatory and EU GMP Annex 1 requirements.
9. Engage hands-on during tech transfer and manufacturing activities, sharing knowledge and building team capabilities.
Key Skills and Requirements:
10. Advanced degree (PhD or MS) in Biological Sciences, Engineering, or a related field.
11. Experience managing complex cGMP drug product manufacturing or development projects.
12. Expertise in drug product technologies, particularly PFS, and familiarity with liquid and lyophilized vial filling processes.
13. Solid knowledge of regulatory requirements, pharmaceutical standards, and validation processes.
14. Strong analytical and problem-solving skills with a data-driven approach to troubleshooting.
15. Excellent communication skills for client interactions, audits, and cross-functional collaboration.
16. Hands-on proactive mentality with the ability to work effectively on the shopfloor.
17. Ability to transfer knowledge, contribute to team development, and support long-term strategy building.
18. Familiarity with project management tools and Minitab is a plus.