Vice President, Drug Product

Role Summary

The Vice President, Drug Product will provide strategic and operational leadership for all aspects of drug product development, manufacturing, and lifecycle management at Soleno Therapeutics. This role will be responsible for overseeing formulation development, process scale-up, commercial manufacturing, technology transfers, and supply continuity for our lead product, Vykat XR (DCCR), and future pipeline assets. The VP will partner closely with leaders in Technical Operations, Quality, Regulatory, CMC, and Commercial to ensure robust and compliant global supply to support Soleno’s commercial and clinical programs.

Responsibilities

• Lead the strategy and execution of all drug product development and manufacturing activities, from late-stage development through commercialization.
• Provide technical oversight and direction for formulation, process design, scale-up, and validation of drug product manufacturing processes.
• Develop and maintain strategic partnerships with CMOs, CDMOs, and raw material suppliers to ensure cost-effective, compliant, and reliable supply.
• Collaborate cross-functionally with Drug Substance, Quality, Regulatory, and Supply Chain to ensure end-to-end alignment within Technical Operations.
• Lead risk assessment and mitigation strategies to ensure supply continuity, quality, and regulatory compliance.
• Oversee process development, technology transfer, and commercial manufacturing for solid oral dosage forms (or other relevant modalities).
• Ensure robust process performance monitoring and continuous improvement of commercial manufacturing processes.
• Partner with Analytical Development to ensure suitable control strategies, release specifications, and product comparability data.
• Provide technical leadership during regulatory submissions (NDA, MAA) and inspections, including authoring and reviewing CMC sections and supporting responses to health authorities.
• Foster a collaborative, solutions-oriented culture aligned with Soleno‚Äôs values of trust, creativity, and accountability.
• Serve as a senior leader within Technical Operations, contributing to department-wide strategies and priorities.
• Develop and manage budgets, forecasts, and timelines for all drug product‚Äìrelated programs.
• Support long-range planning and resource allocation for commercial supply and lifecycle management initiatives.
• Manage vendor performance, contracts, and cost optimization initiatives.
• Other duties as assigned.

Qualifications

• Master‚Äôs degree or Ph.D. in chemical engineering, chemistry, organic chemistry, or a related scientific discipline.
• Minimum of 20 years‚Äô experience. Experience must include small molecules in a pharmaceutical or biotechnology environment while overseeing CMC responsibilities in all stages from pre-clinical to commercialization.
• Exceptional leadership, communication, and decision-making skills; able to thrive in a fast-paced, entrepreneurial environment.
• Strong background in outsourced DP clinical development through commercialization is required, as is experience in outsourced development through commercialization of solid oral dosage forms, modified-release formulations, and pediatric formulations.
• Demonstrated success in managing CDMO/CMO partnerships and driving cross-functional collaboration. Knowledge of GMP quality systems.
• Must possess a strong project leadership presence with excellent organizational skills and strong attention to details; excellent written and verbal communication skills.
• Successful track record of developing collaborative, productive relationships across all functions and levels both internally and externally and the ability to manage and gain support of multiple stakeholders.
• Must possess strong technical judgment; a problem solver with the ability to successfully and proactively identify and manage potential risks across all relevant areas.

Skills

• Technical leadership in drug product development and manufacturing
• CDMO/CMO partnership management
• Regulatory submission support (CMC)
• Strategic planning and budgeting
• Quality systems and GMP knowledge

Education

• Master‚Äôs degree or Ph.D. in chemical engineering, chemistry, organic chemistry, or related field