MSAT Site Lead Synthetics Schaffhausen

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MSAT Site Lead, Synthetics Drug Substance & Drug Product (Schaffhausen)

The MSAT Site Lead provides technical and people leadership for Schaffhausen’s Synthetics Drug Substance and solid oral Drug Product portfolio. The role ensures compliant, reliable, and competitive delivery across product introduction, technology transfer, lifecycle management, validation, investigations, and process performance.

As the single point of accountability for site MSAT, the leader represents Schaffhausen in global and site forums and partners across functions to strengthen product robustness, inspection readiness, supply reliability, and value delivery.

Leadership and Strategy

• Lead and develop the Schaffhausen MSAT team, setting priorities and deploying resources effectively.
• Translate global MSAT, Synthetics platform, and site strategies into measurable local objectives, governance, and risk management.
• Provide the technical voice in site and global leadership forums and promote an end-to-end DS–DP approach through shared standards and knowledge.

Product Lifecycle, Transfers, and Technical Operations

• Own technical support for the commercial portfolio, including process monitoring, troubleshooting, risk assessment, and lifecycle improvement.
• Lead new product introductions, scale-up, transfers, and major changes, including fit-to-plant assessment, documentation, validation, and cross-functional governance.
• Partner with Operations and Value Chain teams to improve process capability, yield, capacity, cost, and supply resilience.
• Lead or support complex investigations, ensuring robust root-cause analysis, effective CAPAs, and organizational learning.
• Act as Technical Owner where appropriate or oversee Technical Owners within the team.

Validation, Quality, Compliance, and Safety

• Provide governance for process validation, cleaning validation, continued verification, and applicable MSAT content in the Site Validation Master Plan, in partnership with site Quality and global subject-matter experts.
• Support health authority inspections and internal or customer audits; serve as MSAT presenter or lead for relevant processes and technical topics.
• Ensure adherence to current GMP, quality systems, process safety, EH&S, environmental, and SOX requirements, with timely escalation and resolution of risk.

Innovation, Digitalization, and Continuous Improvement

• Drive process excellence through standardization, lean practices, data analytics, PAT, automation, and other fit-for-purpose technologies.
• Sponsor improvements that enhance robustness, sustainability, speed, cost, and competitiveness.
• Provide MSAT support for capital projects and technology deployment through qualification and operational readiness.
• Use internal and external networks to identify and scale innovation.

Education

• Bachelor’s degree or equivalent in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or a related discipline; an advanced degree is preferred.

Required Experience and Skills

• At least 8 years of relevant pharmaceutical manufacturing, process development, technical operations, or MSAT experience.
• Strong knowledge of Synthetics Drug Substance and solid oral Drug Product processes and DS–DP interdependencies.
• Experience in technology transfer, lifecycle management, process or cleaning validation, and continued process verification.
• Strong knowledge of GMP, regulatory expectations, quality systems, process safety, and EH&S.
• Demonstrated people and change leadership in a global matrix organization.
• Strong analytical, problem-solving, project, resource, stakeholder, and business-management skills.
• Excellent communication, influencing, and negotiation skills.

Preferred Experience and Skills

• Leadership of multidisciplinary teams supporting both Drug Substance and Drug Product operations.
• Experience with inspections, capital projects, advanced manufacturing technologies, data analytics, and lean principles.
• Demonstrated ability to build effective internal and external partnerships.

• Credo-based, inclusive leadership grounded in integrity and accountability.
• Strategic, customer-focused, and results-oriented thinking with sound judgment under ambiguity.
• Ability to challenge constructively, manage competing interests, influence, simplify, and build organizational capability.

• Fluent in English and German.
• Based in Schaffhausen, Switzerland, with up to approximately 10% domestic and international travel.

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