Purpose:

The Director, Analytical Development’s primary responsibility is to the vision and strategy for the department, plan and ensure timely delivery of program objectives and coach, develop, hire, the scientific talent. The director establishes goals that are consistent with the portfolio and functional priorities and ensures the right balance between near term and longer-term objectives to position the department for sustained success through tangible capability improvement. The director will leverage their analytical development expertise to guide a technically diverse staff of highly specialized scientists and technicians with a strong emphasis on group culture. He/she is a key link between analytical function and other functional groups across AbbVie to ensure seamless partnership and progress on objectives in a collaborative manner.

Responsibilities:

• Lead all activities related to biologics drug substance analytical development from preclinical to on-marketed products within Operations at AbbVie.
• Provide mature, credible analytical CMC leadership and technical expertise for in-depth product understanding for biologics assets at AbbVie.
• Own the development of product control strategy and partner with quality organization on the testing strategy and life-cycle management for drug substance methods.
• Demonstrate a positive senior leadership model for scientists within Operations S&T. Create an environment of scientific excellence and innovation.
• Guide a highly diversified cross functional staff of professionals to ensure that all aspects CMC life cycle management are completed on time, and meet highest scientific, regulatory, quality, and commercial standards.
• Evaluate and introduce new technology with applications in analytical development while assuring the incorporation of knowledge of current regulations, guidance documents and competitive environment into decisions and strategy.
• Provide guidance, create, and implement strategic systems to improve workflows within analytical development including deployment of digital tools, automation, and other lab practices.
• Be a strong partner to process development colleagues to establish the right priority for the right testing for the right samples. Help focus process development through up-front product quality understanding, definition of appropriate targets and working iteratively and collaboratively to refine this over time. Champion QbD principles in CMC development.
• Provide rapid and accurate evaluation of new business opportunities. Develop and communicate cost estimates, business plans, timelines, and contingency plan.
• Identify and recruit resources to accomplish project and departmental objectives within agreed time scope and operating in an open communication environment while 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. Provide effective technical and business leadership at the R&D/Operations interface.
• Develop relationships, interact with, and influence the stakeholders and communicate with senior leadership on issues, risks, and opportunities.
• Own the creation of a high performing team with a strong individual initiative, deep scientific curiosity, and natural environment of working together collaboratively. Coach and develop a strong pool of scientific talent.

Qualifications:

• PhD or equivalent experience in a related scientific discipline with 10+ years of experience in analytical chemistry and/or process development roles, including at least 6+ years of managerial experience in the pharmaceutical industry.
• Strong background and expertise in drug development, marketed product support, technical issue resolution, related technical, manufacturing, regulatory and compliance fields.