Primary Responsibilities
- Partner across ExM Operations, ExM Quality, Business Development, Supply Chain Management, and Global Procurement to support API supply (including intermediates/critical materials) for new product introductions, sustained commercial supply, risk management, and sourcing.
- Coach and develop the team; oversee direct reports’ career development plans.
- Build a high-performance, change- and innovation-focused organization to drive continuous improvement.
- Use operational excellence methodologies to streamline ways of working and improve efficiency/effectiveness.
- Ensure technical excellence in routine supply support to contract manufacturers.
- Lead technical efforts for competitiveness via targeted process optimization.
- Drive capability in Proactive Process Monitoring for robust manufacturing operations and early detection of process issues.
- Promote sharing, curiosity, learning, and end-to-end mindsets for new technologies and introductions.
- Ensure technical capability building for internal and external teams for evolving pipeline needs.
- Build a technical network (internal/external) to rapidly solve complex cross-functional problems.
- Ensure data-driven, safe and compliant resolution of complex technical/business challenges.
- Partner with Operations and Quality Assurance to establish compliant capabilities at partner CMOs.
- Oversee process scale-up/optimization, new technology deployment, pre-approval inspection readiness, validation protocol development, and execution of process validation/continued process verification.
Education Requirement
- Bachelor’s (or Master’s/PhD) in a technical field with 10/7/5 years of relevant pharmaceutical industry experience respectively.
Qualifications
- Leadership experience in Technical Operations, Process Development, Manufacturing, Quality Operations, or Engineering.
- Experience resolving complex technical issues affecting supply continuity.
- API processing experience plus introduction of new technologies/ways of working.
- Knowledge of biocatalysts/enzyme manufacturing, flow chemistry, highly potent compounds, and/or sterile/low bioburden DS manufacturing (advantageous).
- Frequent travel ~25%.