Exec Director, API Synthetic Development

Directs the route selection, design, and scale-up of pharmaceutical ingredient (API) processes – inclusive of instruments and equipment – from the laboratory through pilot and manufacturing scale. Manages the science and engineering underlying the development and implementation of processing technologies and products to achieve cost effectiveness and improved product quality. Independently conducts synthesis and process development activities for preclinical and clinical candidates, including laboratory experimentation for compound preparation. Plans and implements the development of new process formulas, establishes operating equipment specifications and may advise manufacturing techniques and process equipment changes. Acts as liaison with Research and/or Commercial to ensure processes and designs are appropriate for the customer. Selects, develops, and evaluates personnel to ensure the efficient operation of the department. Works on challenges of significant scope in which analysis of situation or data requires executive review and discussion. ResponsibilitiesDrives strategic vision and direction for API Development Directs the design and scale‑up of processes, instruments and equipment from the laboratory through pilot plant and manufacturing scale‑up Manages the science and engineering underlying the development, implementation, and maintenance of process methods and equipment for the production of process formulas, technologies and products to achieve cost effectiveness and improved product quality Plans and implements the development of new process formulas, establishes operating equipment specifications and improves manufacturing techniques and new process equipment production Acts as liaison with research and/or development to ensure processes and designs are compatible Selects, develops and evaluates personnel to ensure the efficient operation of the function Supports off‑site synthesis and interaction with scale‑up/manufacturing contractors Effectively documents research and conducts work in a safe manner in accordance with company and departmental guidelines Performs other duties as assigned Interacts internally and externally with executive level management, requiring negotiation of extremely critical matters Influences policy‑making Leads multiple disparate groups and actively contributes to strategic planning for the larger function Partners with executive leadership team for the function to provide cohesive direction towards company goals Regularly interacts with vendors, regulatory bodies and other external stakeholders exerting influence and negotiating to drive business results Directs and controls the activities of multiple functional areas, divisions, product groups or service area Other duties as assigned