Manager / Senior Manager - MS&T - Drug Product

The Technical Manager / Senior Technical Manager MS&T for Drug Product, Finished Product provides technical expertise on manufacturing and packaging process design, process- and cleaning validation and resolution of technical issues. Acts as responsible Technical Transfer Lead to facilitate Product Transfers for legacy and new development products, performs due diligence evaluations for new projects and act as MS&T representative in an assigned Supplier Relationship Team (SRT) to provide technical & scientific process support to respective Supplier Relationship Teams (SRT).

Your Key Responsibilities

• Represent the technical interface to external supplier to ensure robust product process capability.
• Participate in supplier- and product evaluation and selection process.
• Responsible for validation oversight at the external supplier.
• Ensure successful and well-documented transfers and launches of products with external manufacturing involvement.
• Perform Product/Technical Stewardship for defined key molecules.
• Assess impact of technical changes, technical feasibility and scope / design of technical batches.
• Lead or support root cause investigation of product and process failures.
• Represent the interface to Sandoz internal Global Development (SGD) and supports SGD that new products and processes are well developed for commercial scale and entire product life cycle.
• Contribute to the registration strategy and ensure alignment of (regulatory).

Requirements

• University Degree in Pharmacy, Biotechnology, Chemistry or equivalent (Master is desirable).
• Min. 8 years in pharmaceutical manufacturing (aseptic operations), solid understanding of biotechnology and field of expertise (aseptic operations and device knowledge, ...).
• Demonstrated accomplishments in a global/matrix environment.
• Strong project management experience and problem-solving skills.
• Strong Technical expertise in (sterile) manufacturing process science and drug development.
• Experience with Tech Transfers is a plus.