Senior Small Molecule Manufacturing Subject Matter Expert

Position Overview

The Senior Small Molecule Manufacturing SME will support the development and implementation of the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR®) initiative under Executive Order 14336, a transformative effort aimed at strengthening U.S. pharmaceutical supply chain resiliency and ensuring uninterrupted access to critical generic medicines.

Key Responsibilities

• Strategic Manufacturing Support
  • Development of a resilient domestic API manufacturing and stockpiling strategy for critical generic medicines.
  • Technical expertise to support large-scale reshoring of pharmaceutical manufacturing capabilities.
  • Development of innovative manufacturing approaches that reduce labor intensity, increase operational efficiency, and minimize facility footprint requirements.
  • Evaluation and implementation of scalable manufacturing models capable of supporting national preparedness and emergency response objectives.
• Advanced Manufacturing & Technology Integration
  • Assess and implement emerging pharmaceutical manufacturing technologies, including:
  • Continuous flow chemistry
  • Continuous and modular manufacturing systems
  • Agile and distributed manufacturing models
  • Advanced process analytical technologies (PAT)
  • Real-time process monitoring and metrology
  • Engineered biological and enzymatic production systems
• Data, Analytics & Regulatory Support
  • Leverage large manufacturing and process datasets to improve product quality, process understanding, and operational performance.
  • Support development of data-driven regulatory submissions and validation strategies.
  • Ensure manufacturing approaches align with applicable FDA and other regulatory requirements.
• Manufacturing Operations & Scale-Up
  • Provide end-to-end expertise across API development, process development, manufacturing scale-up, commercial production, and supply chain operations.
  • Identify opportunities to improve reliability, quality, and production efficiency throughout the manufacturing lifecycle.
  • Serve as a technical advisor on facility design, manufacturing strategy, and operational excellence initiatives.

Required Qualifications

• Bachelor’s degree required, Advanced degree strongly preferred in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Biochemical Engineering, Electrical Engineering, Biology, or related technical discipline.
• 15+ years of pharmaceutical manufacturing experience with significant expertise in small molecule drug substance and/or drug product manufacturing.
• Experience in API stability assessment, shelf-life determination, and management of stored material requalification programs to ensure product quality, regulatory compliance, and uninterrupted supply.
• Demonstrated expertise in Key Starting Material (KSM) and starting material sourcing strategy, including supply risk assessment, supplier evaluation, cost of goods (COGS) optimization, and make-versus-buy analysis to support manufacturing and supply chain decisions.
• Proven experience building, operating, leading, or scaling pharmaceutical manufacturing facilities and/or CDMOs.
• Deep understanding of pharmaceutical manufacturing processes, technology transfer, process development, and commercial operations.
• Strong knowledge of FDA-regulated manufacturing environments, including GMP requirements and regulatory expectations.
• Demonstrated ability to work across multiple functional areas and solve complex technical and operational challenges.
• Ability to evaluate emerging technologies and implement innovative manufacturing solutions.

Preferred Qualifications

• Experience with:
• Continuous flow chemistry
• Continuous manufacturing
• Modular manufacturing systems
• Process Analytical Technology (PAT)
• Advanced process controls
• Machine learning and manufacturing analytics
• Patient process development
• Analytical chemistry
• Chemistry development and scale-up
• Enzyme-based or engineered biological production platforms