Primary Responsibilities:
- Partner across ExM Operations, ExM Quality, Business Development, Supply Chain, and Global Procurement to support API supply (intermediates and critical materials) for new product introductions, sustained commercial supply, risk management, and sourcing.
- Lead, coach, and develop a team; oversee career development plans.
- Drive continuous improvement using operational excellence methodologies.
- Ensure technical excellence and competitiveness via process optimization.
- Build capability in Proactive Process Monitoring for robust operations and early issue detection.
- Lead technical network/knowledge management to solve complex, cross-functional problems.
- Ensure safe, compliant resolution of complex technical/business challenges (quality, safety, regulatory, trade compliance).
- Partner with Operations and QA to establish compliant CMO manufacturing capabilities.
- Oversee scale-up/optimization, new technology deployment, pre-approval inspection readiness, validation protocols, and execution of process validation (PPQ) and Continued Process Verification.
Education Requirement:
- BS in a technical field with 10+ years relevant pharma experience; or MS with 7+ years; or PhD with 5+ years.
Qualifications:
- Leadership experience in Technical Operations, Process Development, Manufacturing, Quality Operations, or Engineering.
- Proven expertise in traditional API processing and introducing new technologies/ways of working.
- Knowledge/advantage: biocatalysts/enzyme manufacturing, flow chemistry, highly potent compound processing, and/or sterile/low bioburden DS manufacturing.
- Frequent travel ~25%.