AbbVie Senior Scientist II/Principal Scientist I, Analytical Chemistry - ARD in North Chicago, Illinois
AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie at https://twitter.com/abbvie on Twitter, Facebook at https://www.facebook.com/AbbVieCareers/ or LinkedIn at https://www.linkedin.com/company/abbvie/jobs .
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.
The Analytical R&D group for new biological entities (NBEs) develops antibody drug conjugates (ADC) and other biologics by state of the art analytical technologies.
We are looking for a highly motivated person who can lead the analytical development of new biologic candidates from FIH through registration. The candidate will be the analytical representative on the CMC team and as such will be responsible for developing timelines and executing activities required for drug substance and drug product development. The candidate must be able to mentor junior staff with novel experimental approaches to answer scientific questions to develop and optimize NBE drug product formulations. Working closely with formulation and process development scientists, the candidate will develop productive collaborations and communications with scientific teams.
Section I: Major Responsibilities
Lead analytical characterization and assessment of clinical trial supplies (e.g. GMP compliant stability and release testing).
Lead activities associated with analytical characterization for new biologic compounds.
Lead small project team in the execution and design experiments for method validation studies.
Author and/or review key regulatory documents, laboratory data, technical memos and reports.
Mentor junior staff in troubleshooting of equipment and experimental problems.
Encourage ideas for continuous improvement activities and initiatives within work group.
Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.
Section II: Qualifications:
BS, MS, or PhD in Chemistry, Biochemistry, Pharmacy, or Biology and typically 12-14 (BS), 10-12 (MS), and 4-6 (PhD) years of experience. Previous work experience in a GMP (i.e. QC or equivalent) pharmaceutical laboratory setting is required.
Experience in analytical methodology, such as chromatography, KF, UV and compendial methods and bioanalytical techniques preferred (WCX, HIC, SEC, CGE, icIEF, particle imaging, ELISA and LC-MS).
Previous supervisory experience of laboratory staff (2+ years) preferred.
Experienced in laboratory systems (LIMS, CDS, ELN) preferred.
Statistical knowledge and experience is preferred, e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies.
Key AbbVie Competencies:
Builds strong relationships with peers and cross functionally with partners outside of teams 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.
Level and compensation will be commensurate with experience.
Significant Work Activities
Yes, 10 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.