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 Principal Research Scientist I position, we are seeking a highly motivated, experienced analytical scientist and leader to lead a team of analytical scientists supporting the development of New Chemical Entities (NCEs) drug substance and drug product from pre-clinical through Phase III under GLP and GMP guidelines. The role also includes characterization of Antibody Drug Conjugate (ADC) molecule in support of GLP Pre-Clinical Safety studies. The candidate should have extensive expertise in applying Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulatory guidelines within a R&D environment with a fit for purpose mind set. The candidate will need expertise in the areas of analytical method development, characterization, validation, release, and stability testing. The candidate will ensure the maintenance of a GLP complaint analytical operation.
He/she will lead a team who primarily perform GLP Test Item characterization, cGMP release and stability testing, and interfacing across the NCE project team and fulfill responsibilities of a GLP Principal Investigator. 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 such as Pre-Clinical Safety (PCS), Process R&D (PRD), Formulation Sciences (Pharmaceutics), and Quality Assurance (QA). Perform
- Mentor and coach, a team of analytical scientists on the development of appropriate analytical strategies for GLP characterization involving Drug Substance and Drug Product.
- 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.
- Apply analytical separation and detection modes for complex impurity profiling of pharmaceutical products to further the understanding of emerging cGMP manufacturing processes.
- Responsible for leading the analytical aspects of a project while working with other functional areas to advance projects through the development pipeline.
- Utilize understanding of a range of analytical techniques to conduct research and development studies related to small-molecule drug products, active pharmaceutical ingredients, intermediates, starting materials, impurities and impurity profiling.
- Support new product development with advanced methods development and validations, technical transfer packages, and generation of technical data in support regulatory requirements.
- Highly autonomous and productive in performing laboratory research or method development, requiring only minimal direction from or interaction with supervisor.
- Formulate conclusions and design follow-on experiments based on multidisciplinary data.
- May initiate new areas of investigation that are scientifically meaningful, reliable, and can be incorporated directly into a research or development program.
- Process, interpret, and visualize data to facilitate project team decisions.
- Communicate and collaborate with cross-functional groups and departments.
- Routinely demonstrate scientific initiative and creativity in research or development activities and maintain a high level of productivity in the lab.
- Responsible for method development, testing procedures, and implementation of analytical control strategies to help the advancement of drug discovery candidates.
- Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, and GxP compliance, where applicable.
- Bachelors, Masters, or Ph.D. in Analytical Chemistry typically with a minimum of 14+ (BS), 12+ (MS), or 6+ (Ph.D.) years related industry experience.
- Strong technical background in analytical chemistry, excellent analytical problem-solving skills. Capable of independently developing and troubleshoot analytical methods.
- Hands on experience with HPLC analysis and method development along with expertise and fundamental understanding of spectroscopic techniques.
- Self-motivated, hard-working, detail-oriented individual able to work in a fast-paced team environment.
- Experience in the use of computerized data handling systems.
- High-quality written and oral communication skills and ability to interact effectively with interdisciplinary scientists and engineers.
- Understanding of cGMP, cGLP and regulatory requirements for clinical development and marketing authorizations in the U.S. and OUS
- Advanced degree in Analytical Chemistry.
- Strong understanding of GLP and cGMP requirements.
- Practical knowledge of organic structure, functional groups, chemistry, and modern spectroscopic techniques as applied to small-molecule analytical analysis.
Key Leadership Competencies
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
- Learns fast, grasps the "essence" and can change course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures innovation and manages innovation to reality.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced