AbbVie Analytical Research &Development (Analytical R&D) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products. Our scope includes AbbVie's diverse pipeline of innovative small molecule and therapeutic biologic medicines and spans from the selection of Discovery candidate molecules through the transition of analytical methods and testing to commercial labs to support product launch. We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines. Careers in AbbVie Analytical R&D provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies. We are looking for diverse candidates with strong scientific and leadership experience to join the AbbVie Analytical R&D team and can offer exciting and rewarding career opportunities for these candidates.
For the Analytical Director position, we are seeking a highly motivated, experienced analytical scientist and leader to lead a diverse team of Ph.D., M.S. and B.S. analytical scientists supporting the development of New Chemical Entities (NCEs) drug substance and drug product from early development through commercialization. The candidate should have extensive expertise in the development of robust, fit-for-purpose analytical control strategies, analytical method development, validation and transfer, and analytical understanding for drug substance and drug product process development, scale up and technology transfer. He/she will lead a team that includes analytical project leads who represent global Analytical R&D on cross-functional Chemistry Manufacturing & Control (CMC) teams and are responsible for all analytical program decisions and deliverables to support program advancement through clinical development to commercial launch. The candidate should have experience with submission and approval of Clinical Trial Applications (INDs, IMPDs, etc.) and Marketing Applications (NDAs, MAAs, etc.) for NCEs. He/she must be able to mentor and develop scientists across a range of different experience levels and must foster productive collaborations within the global Analytical R&D organization and with R&D cross-functional partners and across functions such as Operations and Science & Technology (S&T).
- 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.
- 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
Significant Work Activities: N/A
Travel: Yes, 5 % of the Time
Job Type: Experienced