Senior Scientist I, Biologics Analytical R&D, Analytical Development-Early Stage

AbbVie•North Chicago, IL

11h

About The Position

AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's therapeutic biologic products. Our scope includes AbbVie's diverse pipeline of innovative therapeutic biologics medicines, including monoclonal antibodies, antibody drug conjugates (ADC), and other novel modalities, 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 Biologics ARD provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies. The Analytical Development-Early Stage group within Biologics ARD is responsible for support of programs that are preparing for FIH clinical studies. The team leads Stage 1 method development, optimization, and validation. In collaboration with cross-functional partners, the team supports early phase formulation and process development studies. Key deliverables include product control strategies informed by analytical data and method understanding; robust analytical methods suitable for commercial QC labs; comprehensive data packages that drive product and process understanding; clinical supplies release testing and stability studies to establish clinical product dating; substantial clinical trial application submission content.

Requirements

Senior Scientist I PhD (0+ years), Master’s Degree (8+ years), or Bachelor’s Degree (10+ years) in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) with previous laboratory experience.
Practical experience and strong knowledge of protein HPLC (e.g., SEC, IEX, HIC), capillary electrophoresis, and other separation techniques as applied to protein analysis.
Experience developing and transferring bioassays and ELISAs to QC setting in support of early phase release and stability testing
Must possess a solid understanding of protein chemistry and biochemistry, particularly as related to biologics drug development.
Maintain a laboratory notebook in compliance with Good Laboratory/Manufacturing Practices.
Demonstrated independent problem-solving ability in science and technical proficiency.
Demonstrated ability to learn, understand, and master new experimental techniques.
Ability to multitask and work within timelines.
Demonstrated scientific writing skills and strong verbal communication skills.

Nice To Haves

Senior Scientist II PhD in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) with 4+ years of industry experience OR Master’s degree in related fields with 8-10+ years of industry experience
Proficiency and direct experience in large biologics characterization and separation techniques, including various chromatography analytical methods (SEC/HIC/RPLC/IEC), intact or subunit mass analysis, peptide mapping.
Knowledge in key analytical CMC areas, such as risk-based analytical development and method validation, CQAs, reference standard qualification, specifications, comparability.
Familiarity with biologics CE, icIEF, biophysical assays, or binding and functional assays are plus.
Working knowledge of lab automation, good written and oral communication skills, time management skills.
Ability to work independently and collaboratively across functions.
Leverage extensive expertise in Bioassay and ELISA to design, optimize, and execute robust analytical methods in GSP and GMP environments supporting biologics development and characterization.

Responsibilities

Effectively function as a senior research scientist, generating original technical ideas and research or development strategies.
Demonstrate creative “out of the box” thinking to solve difficult problems and champion new analytical technologies to achieve project goals.
Independently responsible for project activities within area of expertise while also contributing within the project team to the overall progress of the program.
Deliver results in a team-oriented setting and willing to work across scientific disciplines to drive programs through critical milestones.
Generate new scientific proposals and lead those efforts.
Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.
Effectively organize and present scientific plans and data.
Author technical documents (e.g., methods, protocols, reports, etc.), scientific publications, presentations, and regulatory documents.
Lead scientific experiments designed to screen platform analytical methods for incoming programs to the Biologics-ARD Early Stage group.