AbbVie Analytical Research & Development, Small Molecule is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's therapeutic small molecule products. Our scope spans from the selection of Discovery candidate molecules through the transition of analytical methods and testing to commercial labs to support process performance qualification (PPQ) and 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 Small Molecule 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 team and can offer exciting and rewarding career opportunities for these candidates.
For the Analytical R&D 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 therapeutic small molecule modalities from early development through commercialization, with a specific focus on antibody drug conjugates (ADC). 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 Small Molecule 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 (BLAs, MAAs, etc.). 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 Chemistry, Formulation, Engineering, Discovery Research, Operations, Quality Assurance and Science & Technology (S&T).
Lead a team of analytical team leaders and scientists working with cross functional R&D partners to develop candidates from early development through NDA approval and launch.
Mentor analytical leads and scientists on the development of phase-appropriate analytical strategies such as analytical method development, product specifications, stability, and comparability to support 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 organization and help position Small Molecule 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, fit-for-purpose regulatory submissions and source reports.
Recruit and develop top talent to create and maintain a productive team of highly skilled scientists and project leaders. Establish and maintain an environment that ensures retention of key talent through continued development opportunities and recognition of key accomplishments.
Encourage ideas and drive for continuous improvement and champion initiatives within the Analytical R&D organization and across R&D partner functions. Evaluate and recommend new technologies for application in the development, manufacture and testing of therapeutic products.
Understand and comply with AbbVie safety, quality and regulatory policies and government regulations.
Ph.D. with at least 14 years of related industry experience or master’s degree with at least 20 years of related industry experience required.
A minimum of 8 years of experience in the management of scientists and technical programs, including technical, financial and performance management with increasing responsibilities.
Strong technical background in analytical chemistry is required; including direct experience with analytical technologies used routinely in the pharmaceutical industries.
Experience must include leadership of analytical development programs for therapeutic candidates across the early- and late-stages of clinical development and participation on cross-functional CMC development teams.
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 for small molecule products including scale-up from pilot plants to commercial facilities and analytical method transfers from R&D to commercial QC testing laboratories.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.