The manager will provide strategic oversight of activities related to the production of sterile liquid and lyophilized parenterals and injectables produced in Lexington, KY. Incumbent oversees a team of manufacturing supervisors and operators, and works to coordinate activities leading to the safe and efficient production of materials, while maintaining the cGMP and regulatory compliance requirements.
- Manages all operational aspects of production, including productivity, cost, planning and daily business processes.
- Ensures manufacturing efficiency and cost reduction through optimum utilization of resources and on-going evaluation and improvement of methods and systems.
- Develops direct reports; coaches, mentors and handles performance reviews
- Ensures compliance with all applicable Piramal and regulatory SOP, cGMP, DEA and Federal safety requirements for the production area and personnel
- Partners with Quality organization to ensure good quality and cGMP practices and their implementation in manufacturing.
- Working with senior leadership, prepares and reviews department budgets and leads cost and efficiency improvement efforts with production.
- Keeps abreast of pharmaceutical industry best practices and market changes
- Ensures all members of the Operations team receive necessary and appropriate training for their job functions.
- Drives manufacturing strategy and ensures alignment with overall business strategy
- Partners with other site leadership and collaborate to find the best possible solution and best practices.
- Implements and oversees multiple projects as assigned.
- Leads, coaches, and trains employees toward team concepts and fosters environment for empowered, high-performance functioning
- Directs work priorities and time-lines and allocate resources to assure overall goals and time-lines are met
- Working with the Quality organization, focuses on reducing product and/or process failures.
- Helps develop and lead efforts regarding continuous improvement of manufacturing performance measures.
- BS in Technical/Engineering/Business Operations or related discipline
- Minimum of 8 years of direct supervisory/management experience in a cGMP pharma or medical device environment.
- Proven leadership and management experience in a pharma or medical device manufacturing environment
- Thorough knowledge of cGMP principals and other industry requirements
- Analytical and problem solving skills
- Strong managerial skills
- Strong communication skills, both verbal and written.