MSAT Site Lead Synthetics

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at  As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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.

• 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.

• 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.

• 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.

• 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…