MSAT Product Science Expert (ROCGJP00026914)
Tasks & Responsibilities:
- Assess performance of manufacturing processes for products in scope and the portfolio and implement improvements related to robustness, speed and efficiency together with safety and sustainability elements. Resolve product issues, risks, and opportunities. Ensure maintenance of the process validated state at CMO
- Authors and reviews technical documents (such as: manufacturing documents,
qualification documents, etc.) and regulatory submissions for products in scope and the portfolio. Contributes to health authority information requests as well as internal and external quality audits - Contribute to and drive process and technology initiatives that deliver improvement to product robustness (i.e. zero defects, manufacturability, supply chain resilience, cost of goods, sustainability) and forward looking capabilities (incl. novel / new technologies) throughout the product lifecycle. This may include transitions of pipeline molecules from development to commercial through product/site launch risk mitigations.
- Drive robustness improvements of manufacturing and/or distribution processes in support of technical transfers and/or integration of new technologies, also translating technical elements of product strategies into technical objectives and outcomes, enabling transparency and PTx prioritization
- Owns and manages process and product technical knowledge for the assigned product families and/or site (ie internal and external manufacturing network)
Your background:
- Min. Bsc/Msc degree in Biotechnology, pharmaceutical or process/chemical engineering
- Min. 5 years of experience as Scientific Expert in the field of large molecules / sterile DRUG PRODUCT manufacturing or development
- Strong Knowledge in interacting and managing an external CMO, especially transferring the needs
- Hands-on knowledge of GMP, microbiology and drug product requirements
- Experience and capability in detail oriented documentation
- Experience in Statistical tools and methodologies (e.g. Minitab) and understanding of data and analytics as well as capability to present them to different audiences
About the company
