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