Principal Research Scientist II, Biologics ARD

3 weeks ago

North Chicago, United States AbbVie, Inc Full time

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

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.

We are looking for a highly motivated person who can drive the early phase analytical development and oversee laboratory activities of new biologics transitioning from Discovery through clinical proof of concept. The candidate will lead a group of motivated scientists in method development, method validation, release and stability testing of new biologic development compounds and provide key data for regulatory submissions. The candidate will serve as the analytical representative on the CMC team for early development programs and as such would be responsible for developing timelines and executing analytical activities required for drug substance and drug product development. The candidate must be able to mentor and develop staff with novel experimental approaches to answer difficult scientific questions . Working closely with formulation and process development scientists, the candidate will d evelop productive collaborations and communications with scientific teams.

Responsibilities:

* Lead activities associated with analytical characterization for new biologic compounds, including assessment of process/formulation development samples and clinical trial supplies, (e.g. GMP compliant release and stability testing).
* Lead the design and execution of experiments for method validation studies.
* Lead analytical strategy development for FIH programs.
* Proactively advise and share knowledge and expert opinions with subordinates, peers, and senior management. Mentor staff in troubleshooting equipment and experimental problems.
* Author and review key regulatory documents, laboratory data, technical memos and reports.
* 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.
*

Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Qualifications

Qualifications:

* BS (16+ years); MS (14+ years) or PhD (8+ years) in Chemistry, Biochemistry, or Biology with 8+ years of previous work experience in a pharmaceutical laboratory setting.
* Experience in analytical methodology (HPLC, KF, UV-Vis, compendial tests and KF). Experience in bioanalytical techniques including SEC, CEX, CE-SDS, icIEF, ELISA, and subvisible particle analysis for parenteral drug products is preferred.
* Previous supervisory experience required (2+ years).
* Statistical knowledge and experience is preferred, e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies. Experience in ELN preferred.
*

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.

Additional Information

Applicable only to applicants

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