Soleno Therapeutics Inc is looking to develop and commercialize novel therapeutics for the treatment of rare diseases, specifically for the PWS community, and needs a Vice President, Drug Product to provide strategic and operational leadership for all aspects of drug product development, manufacturing, and lifecycle management.
Requirements
- Minimum of 20 years’ experience, including small molecules in a pharmaceutical or biotechnology environment while overseeing CMC responsibilities in all stages from pre-clinical to commercialization.
- 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.
- Experience with formulation development, process scale-up, commercial manufacturing, technology transfers, and supply continuity.
- Experience with regulatory submissions (NDA, MAA) and inspections, including authoring and reviewing CMC sections and supporting responses to health authorities.
- Experience with analytical development, including control strategies, release specifications, and product comparability data.
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.
Other
- Master’s degree or Ph.D. in chemical engineering, chemistry, organic chemistry, or a related scientific discipline.
- Exceptional leadership, communication, and decision-making skills; able to thrive in a fast-paced, entrepreneurial environment.
- 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.
