Principal Research Scientist I/II, Analytical Chemistry - ARD

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

The New Biologic Entities (NBE) Analytical Development group develops state-of-the-art analytical techniques for the characterization of antibody drug conjugates (ADC) and other novel biologics.

We are looking for a highly motivated person who can serve as the Analytical Lead for NBE development programs from FIH through registration. The candidate will develop strategies and manage timelines for the analytical deliverables of a given development program. The candidate will also interface with key Analytical R&D functions as well as cross-functional CMC business partners in characterization of new biologic compounds and provide key data for regulatory submissions. The candidate must be able to mentor and develop peers on implementing novel experimental approaches to answer difficult scientific questions. Working closely with formulation and process development program leads, the candidate will foster productive collaborations to support CMC activities.

Major Responsibilities:

• Develop analytical strategies and communicate to Analytical R&D functions and CMC business partners for experimental execution in support of stability studies, product analytical control strategies, comparability studies and extended characterization of new biologics (e.g., mAbs, ADCs, bispecifics and fusion proteins).
• Interpret and identify data trends in key analytical release and stability assays.
• Proactively advise and share knowledge/expert opinions with peers and senior management. Mentor peers in project management and development of analytical strategies.
• Collaborate with third party laboratories for outsourced programs to ensure CMC timelines are met.
• Author and/or review key regulatory documents, laboratory data, technical memos and reports.
• Demonstrate scientific excellence in analytical characterization of biologics internally and externally and build and foster an active network of consortia collaborations
• 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.

Qualifications

Qualifications:

• BS (16+ years); MS (14+ years) or PhD (8+ years) in Chemistry, Biochemistry, or Biology with previous work experience (6+ years) in a pharmaceutical laboratory setting.
• Preferred candidate should have experience in project management/leadership of analytical development activities for new biologic compounds (mAbs, antibody drug conjugates and/or fusion proteins).
• Experience in analytical technologies (HPLC, UV-Vis, compendial tests, and KF). Experience in bioanalytical techniques including SEC, CEX, CE-SDS, icIEF, peptide mapping, bioassay, ELISA, subvisible particle analysis for parenteral drug products preferred.
• Previous supervisory experience of laboratory staff (2+ years) preferred.
• Experienced in laboratory systems (LIMS, CDS, ELN) preferred.
• Statistical knowledge and experience are preferred, e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies.

Key AbbVie Competencies:

• Interact well with diverse groups within function and maintain strong working relationships with internal and external collaborators 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
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
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.