Provides direct oversight, management, and leadership for all commercial products within the site. The Manager, with minimal technical or administrative guidance, has the responsibility for all aspects of technical process support such as but not limited to project management, process monitoring and validation programs within the site. This includes leadership of in-line product support for processes, project definition and demonstration, and process improvements/productivity while assuring compliance with regulatory agencies. These activities involve economic feasibility studies toward objectives assigned or approved by site leadership. The Manager can execute activities or administratively manage a professional staff to ensure objective achievement. The manager is also responsible for development of department employees, resource loading and effectively interface with functional area leaders from other departments to deliver the department and site objectives.

Responsibilities

• Provide technical guidance and continuous improvement support for commercial and new product introductions on day-to-day production and processing issues: problem solving, deviations, manufacturing documentation changes, etc. Source for plant consistency across the Division, share problem-solving activities, and maintain updated technical product history.
• Provide technical assistance with the implementation of changes in manufacturing equipment, batch size, ingredient supplier and experimental batches as needed. Ensure that products and processes are kept in compliance with validation requirements.
• Drive Drug Product Technology transfers to manufacturing, including the financial aspects of each project.
• Supports the commercial manufacturing of third-party products and serves as the technical contact for the customer.
• Identifies and solve technical problems independently for new products and for commercial
  operations.
• Plans data collection, organizes results and applies statistical methodology. Presents numerical information through computer readouts, graphs, charts and tables, written reports and/or other methods.
• Evaluates new process equipment and advises management about areas of opportunity in the application of novel technologies.
• Implement at plant level global technical initiatives as: new technologies, suppliers, methods, etc. and provide tactical perspectives.
• Leads team in troubleshooting and investigation activities.
• Assure fulfillments of environmental, health, and safety (EH&S) requirements and compliance obligations, promote continuous improvement, and consider EH&S aspects during the design and change process.