Director, Analytical R&D - New Chemical Entities (m/f/d)
- Bachelors, Masters, or PhD in Analytical Chemistry with a minimum of 18+ (B.S.), 16+ (M.S.), or 10+ (Ph.D.) years of related industry experience (advanced degree in Analytical Chemistry preferred)
- Strong technical background in analytical chemistry is required; including direct experience with analytical technologies used routinely in the pharmaceutical industry (UPLC/HPLC, GC, IC, ICP, UV-Vis, Karl Fischer, Mass Spectrometry, NMR, X-ray diffraction, and others)
- Experience must include leadership of analytical development programs for NCE pharmaceutical candidates across the early- and late-stages of clinical development and participation on cross-functional CMC development teams
- Demonstrated leadership of technical teams and effective cross-functional communication
- Demonstrated capability to solve critical scientific and business problems
- Demonstrated ability to implement and to grow the capabilities of an analytical organization and develop scientists into future leaders
- Extensive experience in drug substance and drug product process development, scale-up from pilot plants to commercial facilities and analytical method transfers from R&D to commercial QC testing laboratories
- Understanding of cGMP, cGLP and regulatory requirements for clinical development and marketing authorizations in the U.S. and OUS
- Lead a team of analytical team leaders and scientists working with cross functional R&D partners to develop NCE pharmaceutical candidates (RSM to API to DP) from early development through NDA approval and launch.
- Mentor analytical leads and scientists on the development of phase-appropriate analytical strategies such as impurity control, product specifications, stability and comparability for process and formulation changes involving Drug Substance and Drug Product.
- Collaborate across Analytical R&D and partner functions to define analytical and CMC strategies that improve the efficiency and effectiveness of the Analytical R&D organization and help position Analytical R&D as an industry leader relative to peer companies in terms of our science and product development capabilities.
- Form strong alliances with partner functions such as Science & Technology (S&T) and QC Operations to ensure robust and effective analytical method transfers and control strategy implementation.
- Review and edit key regulatory documents, technical reports and analytical method packages to drive high quality regulatory submissions and source reports and ensure fit-for-purpose knowledge management.
- Encourage ideas and drive for continuous improvement and champion initiatives within the Analytical R&D organization and across R&D partner functions.
- Understand and comply with AbbVie safety, quality and regulatory policies and government regulations.
Lake County, Illinois