The Bioanalytical group in Science and Technology supports the analytical needs of AbbVie's pipeline and marketed Biologic products using state of the art analytical technologies. We support manufacturing processes and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.
We are looking for a highly motivated person to join our team. The candidate will be part of a group of motivated scientists who provide in depth characterization of biologic products and provide key insights. Working closely with analytical and process scientists in an integrated group, the candidate will develop productive collaborations and communications with these scientific teams.
Section I: Major Responsibilities
Design and execute experiments for extended characterization of biologics
Support analysis of therapeutic proteins at various stages
Collect data for elucidation of structure and impurity/variant characterization of antibody-based drug materials.
Author and/or review key regulatory documents, laboratory data, technical memos and reports.
Advance science in characterization of novel biologics by generating original ideas for analytical technologies.
Troubleshoot equipment and experimental problems.
Propose ideas for continuous improvement activities and initiatives within work group.
Understand and adhere to corporate standards regarding code of conduct, safety and GXP compliance.
BS (10+ years); MS (4+ years) or PhD in Chemistry, Biochemistry, or Biology, Ph.D. on protein analysis with mass spectrometry preferred.
Experiences with Bruker MS instrumentation and software preferred.
Previous work experience in a pharmaceutical laboratory setting preferred. Experience with late-stage therapeutic protein characterization for BLA preferred. Experiences with regulatory document drafting preferred.
Extensive experiences with protein characterization using LC/MS and LC/MS/MS based techniques, such as intact mass analysis, peptide mapping, disulfide mapping, etc.
Strong knowledge on protein chemistry. Familiar with common protein post-translational modifications and characterization methods.
Experiences with characterization of protein's size and charge heterogeneities.
Previous experiences with studies on antibody structure-function relationship preferred. Experiences with CQA assessment preferred.
HPLC and LC/MS method development experience. Experience with development and execution of methods for characterization of product-related impurities/variants preferred.
Experience in other advanced bioanalytical techniques, such as cIEF, CE-SDS, SEC-MALS, AUC, CD, Biacore, particle analysis preferred.
Good communication and interpersonal skills
Experience with GMP and ELN preferred.
Key AbbVie Competencies:
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
- 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.