2 program management jobs found in Wilmington, OH

Alkermes, Inc. Director, Validation Overview Provide leadership for all validation activities within Alkermes organization including clinical and commercial manufacturing support via facilities/equipment/filter/cleaning & manufacturing process validation, capital project support via commissioning and qualification, automation systems qualification, and oversite of entire validation program. Position includes management responsibilities for internal and contractual employees. This position description/summary reflects management's assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned. Responsibilities Development and oversight of site validation program to ensure compliance with cGMPs, FDA and EU guidelines. This includes guideline and policy development and enforcement. Responsible for preparation and management of side validation budget which includes clinical & commercial operations support and capital...

Alkermes, Inc. Engineering leadership position for degreed Engineer/Manager with experience in pharmaceutical operations and knowledge of facility equipment/utilities. Position has responsibility for supervising/directing internal engineering resources, as well as contract service providers, to ensure business objectives are met and site facilities, utilities and equipment meet business requirements in a safe and compliant manner. Responsibilities KEY DUTIES: Ensure engineering department resources are responsive and effective in meeting the tactical and strategic needs of the site. Development and implementation of process and reliability improvement projects. Provide oversight to relationships with key vendors, A&E firms and engineering service providers. Ensure good project management practices are applied within department. Assist maintenance and manufacturing with systems operation, preventive maintenance, and specification and procurement of replacement...