The Process Engineering department supports technical and scientific activities related to the manufacture of pharmaceutical products in AbbVie facilities or in contract facilities. The Director, through his/her section managers and direct reporting lines, will manage a technically diverse staff of highly specialized engineers and scientists. He/she is a key link between development organizations and operations/third party contract manufacturers and ensures a seamless link between pilot scale and full-scale manufacture. The director is accountable for all the activities of the department and provides technical/scientific and business leadership for the department. The director partners with manufacturing and quality in the identification, definition, and execution of projects and delivers technical requirements for the launch of products and supports the development of innovative solutions to problems and opportunities.
Responsibilities
- Communicates and collaborates with internal (manufacturing, quality, engineering, S&T and other areas) and external partners to provide effective technical and business leadership in line with site goals and objectives.
- Maintain and direct a highly diversified cross functional staff of professionals to ensure that all aspects of CMC life cycle management are completed on time, within budget and meet highest scientific, regulatory, quality, marketing and commercial standards
- Develops engineering objectives and strategies that advance the site, and continually looks for opportunities for process optimization, cost avoidance and cost reduction.
- Develop and communicate cost estimates, business plans, timelines and contingency plans to accomplish project and departmental objectives within agreed time scope.
- Participate in capital plan input and capital project execution to advance manufacturing capabilities
- Make final decisions related to project responsibilities
- Represent AbbVie during audits to regulatory agencies (US/ROW as appropriate) by supplying verbal or written information with active participation.
- Responsible for ensuring that all members of the Engineering team follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
- Provide leadership, coaching, training, and mentoring to direct reports. Negotiates, secures, oversees and ensures that all resources are available to meet the demands of the projects and site goals.