About the Role: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.Your Contributions (include, but are not limited to):Drives strategic vision and direction for API DevelopmentDirects the design and scale-up of processes, instruments and equipment from the laboratory through pilot plant and manufacturing scale-upManages 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 qualityPlans and implements the development of new process formulas, establishes operating equipment specifications and improves manufacturing techniques and new process equipment productionActs 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 functionSupports off-site synthesis and interaction with scale-up/ manufacturing contractorsEffectively documents research and conducts work in a safe manner in accordance with company and departmental guidelinesPerforms other duties as assignedInteracts internally and externally with executive level management, requiring negotiation of extremely critical matters. Influences policy-makingLeads multiple disparate groups and actively contributes to strategic planning for the larger functionPartners with executive leadership team for the function to provide cohesive direction towards company goalsRegularly interacts with vendors, regulatory bodies and other external stakeholders exerting influence and negotiating to drive business resultsDirects and controls the activities of multiple functional areas, divisions, product groups or service areaOther duties as assignedRequirements:BS/BA degree in Chemistry or similar discipline and 16+ years of experience in pharmaceutical/ process development field and extensive previous leadership experiences also required ORMaster's degree in Chemistry or similar discipline and 14+ years of similar experience noted above ORPhD in Chemistry or similar discipline AND 12+ years of similar experience noted aboveA thorough understanding of organic chemistry and process chemistry as well as current literature is requiredManufacturing expertise in Chemical DevelopmentGood understanding of cGMP requirements in API manufacturing as demonstrated through past and present training and responsibilitiesMust have a demonstrated track record of managing multiple programs, resources and staffMust have extensive expertise in working with CRO/CMO's both as a lead and a team memberActs as a "trusted advisor" across the company and may be recognized as an external expertProvides strategy, vision and direction regarding issues that may have company-wide impactRequires in-depth knowledge of the functional area, business strategies, and the company's goalsPossesses industry-leading knowledgeMust be self-motivated, detail-oriented, decisiveAbility to quickly learn and think independentlyExcellent interpersonal & communication skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside the CompanyExcellent managerial skills and experience fostering career development of direct and indirect reportsDemonstrated ability to influence and lead others