The Operations Science & Technology department supports technical and scientific activities related to the manufacture of pharmaceutical products in AbbVie facilities or in contract facilities. The director establishes goals that are consistent with development, manufacturing and customer requirements, implements plans/policies, assigns duties and responsibilities, and controls subordinates performance to meet division goals and commitments. The director through his/her section managers and direct reporting lines will manage a technically diverse staff of highly specialized scientists and technicians. 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.

Responsibilities:

• Provide mature, credible CMC leadership at AbbVie. Mentor and support development of people managers and future leaders. Coach scientists/engineers within the team to develop cross-functional CMC experience.
• Provide a positive leadership model for scientists within Product Development Science & Technology. Maintain and direct a highly diversified cross functional staff of professionals to ensure that all aspects of CMC development are completed on time and meet highest scientific, regulatory, quality, and commercial standards
• Drive development of platform technologies and innovation to enable operational efficiency and cost of goods reduction.
• Provide rapid and accurate evaluation of new business opportunities
• Develop and communicate cost estimates, business plans, timelines and contingency plans . Distill technical and cross-functional updates (timelines, deliverables, results) to provide concise, effective, and clear updates across programs for leadership.
• Identify and recruit resources to accomplish project and departmental objectives within agreed time scope, and operating in an open communication environment whilst stressing scientific/compliance excellence
• Make go/no-go decisions related to project responsibilities
• Represent AbbVie to regulatory agencies (US/ROW as appropriate) by supplying verbal or written information and/or participation in face-to-face meetings for responsible activities. Operate cross-functionally and maximize relationships with key CMC stakeholders including R&D, manufacturing, regulatory, quality, and analytical development.