Principal Research Scientist I

About the Role

AbbVie is seeking a highly motivated Principal Research Scientist to join the Advanced Characterization Group (ACG) within the Analytical Development (AD) department at the AbbVie Bioresearch Center in Worcester, MA. This role involves developing a comprehensive analytical characterization strategy for biologics, including mAbs, ADCs, bi-specifics, fusion proteins, and AAVs. The position requires a strategic thinker with a robust technical background in analytics, leadership skills, and the ability to manage complex projects and cross-functional teams.

The AD group is responsible for the qualification and execution of analytical methods and characterization studies to support AbbVie's biopharmaceutical pipeline from discovery through commercial stages.

Responsibilities

• Lead the extended characterization strategy for ACG by collaborating with a team of scientists to meet the demands of biologic portfolio development.
• Independently lead, perform, and review LC-MS analyses (e.g., intact, reduced, sub-unit, peptide mapping, and disulfide bond mapping) of AbbVie's biologics to provide sequence verification, post-translational modification profiles, sequence variant levels, and disulfide bond profiles.
• Design, execute, and review experiments for method development and/or investigations.
• Collaborate cross-departmentally to develop the most effective approach for biologic development.
• Drive identification, evaluation, and implementation of new technologies.
• Represent the analytical function in the CMC program team; participate in and lead the development of analytical control strategy for biologic programs.
• Author and review filing documents and regulatory responses.
• Contribute to the operation strategy development in Analytical Development; foster close collaboration within the department and across functions for effective execution of department goals.
• Develop a culture of continuous learning and growth in the group and create development opportunities for team members.
• Function as a principal investigator, generating original technical ideas and research or development strategies.
• Demonstrate creative, out-of-the-box thinking to solve difficult problems and champion new technologies to achieve project goals.
• Serve as a recognized expert in the discipline within the company and potentially externally.
• Act as the primary author of publications, presentations, regulatory documents, and/or primary inventor of patents.
• Present at leading scientific conferences.
• Mentor and supervise a team of one or more scientists and evaluate their performance.

Qualifications

• BS or equivalent education with typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in analytical chemistry, biochemistry, or a related scientific discipline.
• Demonstrated expertise in LC-MS-based characterization of biologics, including intact mass analysis, peptide mapping, post-translational modification profiling, sequence variant analysis, and disulfide bond mapping, with extensive hands-on experience in chromatography, electrophoresis, and other analytical techniques.
• Proven track record of leading analytical method development, qualification, and transfer activities of biophysical and biochemical methods for products and intermediates in an analytical development or biopharmaceutical environment.
• Hands-on experience in IND, IMPD, and BLA authoring, review, submission, and regulatory response, with strong knowledge of CMC analytical and regulatory requirements, including CQA assessment, analytical comparability, and structure-function relationship reports.
• Experience representing the analytical function on CMC program teams, contributing to analytical control strategy development, and working effectively cross-functionally.
• Demonstrated ability to function as a principal investigator, generating original technical ideas and research or development strategies, with a proven record of independent thought, creativity, and scientific accomplishment.
• Experience as a primary author of publications, presentations, patents, and regulatory documents, with strong scientific communication skills, including presenting at leading scientific conferences.
• Proven ability to mentor and develop scientific teams, fostering a culture of continuous learning and growth.
• Self-motivated with the ability to act with urgency and passion; resourceful, enthusiastic, and results-oriented.
• Ability to make thoughtful, integrated, timely, and meaningful recommendations and/or decisions while working collaboratively by incorporating diverse perspectives.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in long-term incentive programs.