Drug Product MSAT Process Specialist (m/f/d)

Responsibilities

• Support Product Technical Leads and Product Stewards to ensure process industrialization (e.g. facility t and manufacturability, PPQ support as needed, etc…), coordinate and execute process gap assessments, integrating identified risks into the risk log and developing mitigation strategies
• Drive systematic process and continuous technical product health and supply improvements based on insights, including second supply and change source strategies
• Execute validated state support activities, such as WCB shipment, sample coordination for additional studies, and non-routine sampling planning, and respond to evolving conditions to ensure compliance (e.g. VICs, RCAs, etc.)
• Provide hands-on second-level support (commercial product support) in the case of investigations, CAPAs and troubleshoot in close partnership with the internal and external manufacturing network
• Lead non-product specific RCAs and investigations on behalf of the internal manufacturing network and ensure the implementation of network initiatives aligned and prioritized with manufacturing site plans
• Leverage the pilot plant team to enable real-life and scaled experimentation to support process related projects (including validation studies) as well as process transfer to manufacturing sites
• Incorporate/execute portfolio-wide impacting aspects (e.g. direct material changes; Health Authority requirements; etc.); perform defined technical Product Life Cycle activities to ensure product robustness from development through divestment
• Execute process-related mitigation of complaints and deployment of CAPAs across multiple sites or products as well as drive technical sustainability improvements for product, process, and technology, including digital advancements
• Closely collaborates with global and site functions (sometimes external) and leadership, including other gMSAT and PTT teams, particularly close partnership with E2E Product Technical Leads and DS or DP Technical Leads
• Serve as a digital enabler translating business needs to digital strategy and digital product development teams

Profile

• B.S. or M.S. degree in Chemical, Biochemical Engineering, or related discipline
• Relevant industrial experience in platform specific technical process development, process engineering or manufacturing operations (e.g. DS Bio, DP SM, etc.)
• PhD can be of advantage
• Demonstrated experience in process engineering, technical process development, process validation or technology transfer, with pharmaceutical quality systems and industry-wide guidelines pertinent to platform specific process development and manufacturing, with regulatory submission and health authority requirements, and with platform specific technology, processes and equipment
• Advanced level of verbal and written communication skills (e.g., ability to define and articulate team deliverables) incl. towards senior leadership
• Fluency in English is required, German is of advantage
• 10% travel required

Benefits

• Fascinating, innovative environment in an international atmosphere
• A very renowned company