Scientist II, Immunology
The Immunology group in the Department of Non-Clinical and Translational Sciences is seeking a 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 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.
- Develop and execute robust bioanalytical (ligand binding and cell-based) assays to support in vivo studies. These assays will focus initially on immunogenicity prediction, quantitation of target protein, drug (pharmacokinetics) as well as immunogenicity to assess tolerability and exposure of the drug candidates.
- Work closely with immunoassays, cell culture, ex-vivo assays to contribute to activities related to the immune response to therapeutics.
- Work on experimental design, troubleshooting, assay optimization and data interpretation as needed.
- Author SOPs and tech transfer/qualification/validation of documentation and support tech transfer to external CROs.
- Design and conduct experiments internally and at external bioanalytical labs and interpret results to evaluate and characterize drug-induced immunomodulation of novel therapeutics
- 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.
- Evaluate new assay technologies and other applications for improved performance and efficiency of laboratory activities.
- Prepare analytical sections relating to immunogenicity in clinical protocols, investigator brochures, product labels, and regulatory submission documents.
- Prepare presentations and act as Immunology Project Representative internally and externally.
- Maintain awareness of current developments in the field through comprehensive reading of the literature and attendance at appropriate scientific meetings.
- The successful candidate is required to have Bachelor’s degree or equivalent education and typically 7 years of experience, Master’s Degree or equivalent education and typically 5+ years of experience, PhD and no or minimum experience necessary 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.
- 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: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced