Business: Pharma Solution Department: Technical Services Group Location: Lexington Job Overview Responsible for the production process development, scale up, and commercialization of parenteral pharmaceutical products. As a discipline of engineering, this position includes all product and process activities related to the manufacture of new products. Reporting Structure Job title of immediate supervisor/manager: Director, technical operations Skip level supervisor/manager: Avp & site head Education requirements: * Bachelor's degree in mechanical, biological, chemical engineering; or equivalent years of field experience Experience * 5-7 years of working within pharmaceutical manufacturing/development environment, including development of processes and products * Formal leadership/management experience * Experience working within aseptic or lyophilization manufacturing * Contract manufacturing experience strongly preferred Functional or technical skills: * Well versed in quality by design and scale up of pharmaceutical products * Knowledge and understanding of the regulatory approval process for us, eu, and jp * Expertise in product scale up * Knowledge and understanding of cgmps; knowledge of cgmp validation requirements and techniques. * Knowledge and experience in cgmp ca/pa, root-cause analysis, risk assessment and investigation tools and techniques * Experience managing direct reports * Seasoned communicator, ability to interface effectively with all levels of the organization and clients * Proficiency using microsoft office applications (word, excel, powerpoint) * Ability to effectively lead cross-functional teams Key Responsibilities * Responsible for design, project management, implementation, enhancement and validation of new and existing systems, processes, and equipment to support the transfer of new products from r&d to clinical and commercial manufacturing * Manage a team of process engineers to tech transfer new products and develop the product for commercial manufacturing including the development and challenging of critical quality parameters and attributes (cpp's and cqa's) including qtpp, scale up report, and final product specific technical documentation following qbd q8, q9, and q10 * Responsible for the development of robust and repeatable commercial processes * Responsible for the design and fit for purpose equipment, processes and technology selections to ensure reliable and repeatable processes that can be easily followed by the manufacturing operations team * Primary subject matter expert (sme) for all commerical/clinical manufacturing processes * Interface with clients and regulators * Identify and assign continuous improvement projects * Represents technical subject matter expert (sme) in product development, scale up, and optimization of new products. * Supports day-to-day production and maintenance activities as required for product specific attributes, characteristics, and behavior * Provides training support as required * Participates in deviation investigations to identify root causes and define corrective and preventive actions (ca/pa) as related to product chemistry and manufacturing properties