Principal Research Scientist I

AbbVie•Worcester, MA

18h•Onsite

About The Position

AbbVie is searching for a highly motivated individual to fill a Principal Research Scientist position in the Advanced Characterization Group (ACG) within the Analytical Development (AD) department at AbbVie Bioresearch Center in Worcester, MA to develop a comprehensive analytical characterization strategy for mAbs, ADCs, bi-specifics, fusion proteins, AAVs etc. This position calls for a strategic thinker with a robust technical background in analytics, coupled with the ability to lead cross-functional teams, manage intricate projects, and communicate effectively with stakeholders. The AD group is responsible for qualification and execution of analytical methods and characterization studies to provide product and process understanding of AbbVie's biopharmaceutical pipeline from discovery through commercial stages. The successful candidate will be responsible for defining and executing analytical characterization strategies for biologics development, leading the efforts in establishing protein characterization workflows and practices, especially in characterizing late-stage biotherapeutic products using liquid chromatography mass spectrometry (LC-MS), spectroscopy, and various other biophysical assays. In this role, the individual will directly lead research and project activities and support the professional development of a group of scientists by effectively mentoring, guiding, and/or supervising scientific personnel. The individual will independently conceive, execute, and communicate novel multi-disciplinary research and development strategies that achieve project and area goals, serving as a lead scientist on their own projects while contributing scientific insights across multiple others. As a key member of the ACG team, the successful candidate will interact effectively and transparently with team members and group leaders across Analytical Development, Process Sciences, Manufacturing Sciences, Quality Control, Quality Assurance, and CMC Project Management, and will act as lab manager overseeing the mass spectrometry and biophysical characterization lab at the Worcester site.

Requirements

BS or equivalent education and extensive, 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.
Demonstrated 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 in anticipating and responding to overall program development needs.
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.
Experienced and demonstrated success 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 and take corresponding actions, while working collaboratively by incorporating diverse perspectives and appropriately managing relationships to strengthen decision-making.

Responsibilities

Lead the extended characterization strategy for ACG by working with a group 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-department to develop the most effective approach to meet the demands of 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 members of the group.
Effectively 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.
Recognized and sought out as an expert in his/her discipline within the company and possibly externally.
Primary author of publications, presentations, regulatory documents and/or primary inventor of patents.
Present at leading scientific conferences.
Mentor/supervise a team of one or more and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.