Director, Upstream Process Development

Under the general direction the Deputy Director or designee, the Director of Process Development will lead and expand the process development function.  The Associate Director will oversee the development and implementation of new manufacturing procedures for manufacturing. This position will work closely with analytical and manufacturing groups. MAJOR RESPONSIBILITIES: Oversee overall process development, technology transfer and product manufacture according to Food and Drug Administration (FDA) guidelines and Good Manufacturing Practices (GMP). Oversee the design and scale-up processes, instruments and equipment used to perform the process development and manufacturing functions. Hire, manage, and train staff.   Plan and assign projects to meet departmental and organizational objectives. Provide guidance and direction to staff; establishing expectations, defining roles, supporting career development and managing performance Oversee the optimization of production of products manufacturing, assuring compliance with GMP and FDA regulations Develop the operations budget including capital requirements Oversee technology and manufacturing process transfer, providing product for applicable clinical trials as required Provide leadership and direction imperative for the successful growth and operations within this Process Development Department and relationships with internal and external development efforts. Oversee the development of efficient cell culture processes Plan and manage strategy for process design, optimization, scale-up, technology transfer and process troubleshooting to meet project timelines and company goals Provide scientific and technical leadership for pre-clinical projects and projects in clinical development and technical support for commercial product Manage cell culture process development activities Develop, scale-up and trouble-shoot production Prepare written documentation as necessary to facilitate transfer of manufacturing process to manufacturing groups and to inform senior staff of project progress and issues that may arise Perform additional duties as required. REQUIRED QUALIFICATIONS: PhD in Life Sciences or Chemical/Biochemical Engineering or equivalent experience 8-10 years of process development experience Strong written and verbal communication skills along with the ability to work independently and on multidisciplinary teams are essential. Prior experience working in a cGMP environment.
Salary Range: NA
Minimum Qualification
8 - 10 years

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