Senior Small Molecule Manufacturing Subject Matter Expert

Senior Small Molecule Manufacturing Subject Matter Expert (SME) with focus within either of these disciplines:

Small Molecule Validation/Scale-Up Engineering

Small Molecule Process/Product Development

Location: Remote (U.S.-based) with approximately 20–25% travel

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.

This role will help design and advance innovative approaches for domestic manufacturing of Active Pharmaceutical Ingredients (APIs) and finished drug products while supporting the creation of a strategic national reserve of critical active pharmaceutical ingredients. The initiative seeks to establish a resilient, agile, and distributed manufacturing ecosystem capable of rapidly converting API inventories into finished products during emergencies or supply disruptions.

The ideal candidate combines deep experience in traditional pharmaceutical manufacturing with a demonstrated ability to embrace emerging technologies and novel manufacturing paradigms. This individual will serve as a technical leader helping redefine how pharmaceutical products are developed, manufactured, stockpiled, and deployed in the United States.

Key Responsibilities

Strategic Manufacturing

• Support development of a resilient domestic API manufacturing and stockpiling strategy for critical generic medicines.
• Provide technical expertise to support large-scale reshoring of pharmaceutical manufacturing capabilities.
• Develop innovative manufacturing approaches that reduce labor intensity, increase operational efficiency, and minimize facility footprint requirements.
• Evaluate and implement 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
• Identify opportunities to integrate automation, digital manufacturing, and advanced analytics into API and finished product manufacturing operations.
• Collaborate with multidisciplinary teams to develop next-generation manufacturing solutions for small molecule drug products.

Data, Analytics & Regulatory Support

• Leverage large manufacturing and process datasets to improve product quality, process understanding, and operational performance.
• Assess applications of machine learning and advanced analytics within pharmaceutical manufacturing environments.
• 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.
• Support design, startup, optimization, and operation of pharmaceutical manufacturing facilities and contract development and manufacturing organizations (CDMOs).
• 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
  • Pharmaceutical process development
  • Analytical chemistry
  • Chemistry development and scale-up
  • Enzyme-based or engineered biological production platforms
• Experience integrating manufacturing data systems for regulatory compliance, validation, and process optimization.
• Background spanning multiple disciplines (e.g., engineering, chemistry, biology, manufacturing operations, and regulatory affairs).
• Individuals with unconventional career paths combining engineering and biological sciences expertise are strongly encouraged to apply.

Must be a US Citizen or a Full Green Card holder.