The NPI Launch Sitewill lead responsibility 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.
Qualifications
- M.Sc. in a relevant Science area and extensive experience in a "hands on" Process Engineering or development for new product introduction position.
- Experience of managing and leading professional teams that include Engineers and or Scientist personnel.
- Experience leading product transfer and New Product Introduction projects.
- Regulatory filing experience as well as familiarity with HA audits.
- Excellent communication and interpersonal skills for interaction with both internal departments and other AbbVie sites worldwide (QA, Validation, IS, EHS, R&D, S&T).
- Computer literate with knowledge of statistical methods, data assimilation and interpretation.
