The Associate Director Technical Operations will report to the Director of the Tech Ops business unit and be responsible for the Site New Product Introduction Programs. This position has responsibility for providing direct oversight, management, and leadership with minimal technical or administrative guidance, as well as 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.
Main duties & responsibilities:
- Lead personnel (team of 7-9) responsible for New Product Introduction Programs of the site for Biologics.
- Drive Drug Product Technology transfers to manufacturing, including the financial aspects of each project.
- 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.
- Identify and solve technical problems independently for new products and for commercial operations.
- Plan data collection organizes results and applies statistical methodology. Presents numerical information through computer readouts, graphs, charts and tables, written reports and/or other methods.
- Evaluate 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.
- Assure fulfilments 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.