AbbVie

Senior Scientist, Immunology

Employer
AbbVie
Location
Irvine, California
Posted
Jul 16, 2021
Ref
2111824
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.

Summary:

The Immunology group in the Department of Non-Clinical and Translational Sciences is seeking a Senior Scientist, Immunology.  As a member of multidisciplinary teams, this individual will apply his or her immunology expertise as it relates to immune response to therapeutics and immunoassay development in support of AbbVie’s biologics portfolio.  This role serves as an expert in in vitro and ex vivo assays with the goal of advancing knowledge and understanding the cause of unintended immunological consequences during drug development. The candidate will lead the development, validation, transfer, and troubleshooting of immunoassays and cell-based assays (including pharmacokinetic, immunogenicity prediction tools, immunogenicity assays, biomarkers and others as needed).

The ideal candidate is proactive, inquisitive and a self-starter who is eager to learn and thrives in fast paced environment. Hands-on laboratory experience in support of biologics drug development and within a matrixed team environment is preferred.

Responsibilities:

  • Evaluate the immunogenicity risk by developing and executing novel bioanalytical assays to support cell-based and in vivo studies. These assays will focus initially on immunogenicity prediction, detection and quantitation of target protein, drug as well as immunogenicity in understanding tolerability and exposure of the drug candidates.
  • Propose novel assays to identify the immunogenic potential and identify immunogenicity risk mitigation strategies to modulate immune responses.
  • Evaluate new assay technologies and other applications for improved performance and efficiency of laboratory activities; ensuring that all studies are aligned with regulatory agency guidelines.
  • Design and conduct experiments internally and at external bioanalytical labs and interpret results to evaluate and characterize drug-induced immunomodulation of novel therapeutics.
  • Strategic planning, execution and reporting of nonclinical and clinical studies; representing Immunology function in the Project Strategy Team settings.
  • Communicate with internal and external entities, including vendors, CROs and collaborators to ensure obligations are met with respect to assay transfer/qualification/validation of documentation.
  • Provide scientific oversight to contracted regulated clinical and nonclinical bioanalyses.
  • Develop close and effective partnerships with other nonclinical and clinical pharmacology scientists, safety scientists, research scientists, clinicians, and project teams to foster a collaborative work environment.
  • Complete projects and prepare reports appropriate for corporate and regulatory agencies within agreed timelines. 
  • Assist and/or train others when appropriate
  • Prepare analytical sections relating to immunogenicity in clinical protocols, investigator brochures, product labels, and regulatory submission documents.
  • Maintain awareness of current developments in the field through comprehensive reading of the literature and attendance at appropriate scientific meetings.  

Qualifications

Basic:

  • The successful candidate is required to have Ph.D. in a discipline of biological sciences (i.e., Immunology, Biochemistry, Cell Biology, Bioanalytical or a related field)
  • Experience with biologics projects is required.
  • Knowledge of relevant global health authority guidelines and industry practices.
  • Knowledge in basic cell biology, immunology or pharmacology space.
  • This position requires the individual to work with and in areas requiring select agents and Toxins access (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements.  AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

Preferred Skills and Experience:

  • 2+ years pharmaceutical industry experience is preferred.
  • Experience with guidelines that are used in GLP/GCP compliant environment.
  • Hands-on laboratory experiences with basic immunology assays (flow cytometry, ligand binding assay such as ELISA/ELISPOT, cellular biomarker and translational assays, and primary cell isolation and culture) are preferred.
  • Experience with relevant technology such as Singulex/Quanterix/MSD/Luminex/Gyros/ ELISA, qPCR, and other cell-based assays supporting nonclinical and clinical studies.
  • Experience acting as a project team representative and presenting data and results.

Competencies:

  • Excellent written and oral communication skills to effectively communicate complex research findings and recommendations and seek to excel in a multi-disciplinary team environment.
  • Ability for critical thinking and strong analytical skills to evaluate complex information for the identification of key scientific findings related to projects.
  • Ability to prioritize and manage multiple projects and activities while meeting tight deadlines
  • Maintains excellent working relationships with colleagues and collaborators.
  • Independent, innovative, and creative thinker.
  • Excellent collaboration, communication and decision-making skills.
  • Ability to multi-task as needed in a dynamic environment.
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.

Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.