Principal Research Scientist II
About The Position
AbbVie Operations Parenteral Product Development Science & Technology (PDS&T) is a global organization responsible for CMC activities related to the development and commercialization of AbbVie’s parenteral products. The Biologics Analytical group supports programs transitioning from development to optimization and commercialization. It leads final analytical method development, optimization, and validation to ensure methods are suitable for commercial QC laboratories. Its deliverables include product control strategies informed by analytical data and method understanding, robust methods for commercial QC use, data packages that advance product and process understanding, stability studies to establish commercial product dating, and content for marketing application submissions. The Principal Research Scientist II will oversee laboratory activities in the Biologics Analytical group and provide leadership and talent development for scientists working on late-stage biologics products. The role leads analytical characterization and laboratory work, guides scientific study execution and troubleshooting, manages laboratory standards and documentation, and contributes to project progress. The position also develops and presents scientific plans and data and authors technical, scientific, and regulatory documents.
Requirements
- PhD with 8 or more years of experience, Master’s degree with 14 or more years, or Bachelor’s degree with 16 or more years in a scientific discipline such as Analytical Chemistry, Biochemistry, or Biology, with previous laboratory experience.
- Previous supervisory experience managing teams.
- Practical experience with method validation and working in a GMP environment, including designing studies, authoring protocols and reports, and laboratory notebook documentation.
- Ability to multitask and work within timelines.
- Demonstrated scientific writing skills and strong verbal communication skills.
Nice To Haves
- Experience with investigations, validation events, out-of-specification, or out-of-trend evaluations.
- Familiarity with analytical Quality by Design (AQbD).
- Practical experience and strong knowledge of protein HPLC, such as SEC, IEX, and HIC, capillary electrophoresis, and other separation techniques as applied to protein analysis.
- Solid understanding of protein chemistry and biochemistry, particularly as related to biologics drug development.
Responsibilities
- Provide leadership and talent development for a team of scientists responsible for late-stage biologics products, including monoclonal antibodies, antibody drug conjugates, and bispecific antibodies.
- Lead analytical characterization activities for late-stage biologics compounds, including assessment of process and formulation development samples, feasibility studies, and clinical and commercial in-use studies.
- Troubleshoot methods, examine data holistically, and guide and advise scientists through study execution.
- Manage laboratory activities, including established lab standards and best practices, documentation, and verification.
- Independently manage project activities within the area of expertise and contribute to overall program progress as part of the project team.
- Work across scientific disciplines and deliver results in a team-oriented setting to advance programs through critical milestones.
- Organize and present scientific plans and data.
- Author technical documents such as methods, protocols, and reports, as well as scientific publications, presentations, and regulatory documents.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
