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.
If you are having difficulty in applying or if you have any questions, please contact Antoine Mortiaux at a.mortiaux@proclinical.com.
Apply Now:
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