The Immunology group in the Department of Non-Clinical and Translational Sciences is seeking a Senior Scientist II, Immunology. As a member of multidisciplinary teams, this individual will contribute, through their immunology expertise as it relates to immune response to therapeutics by developing in vitro models for drug safety assessment, will contribute to AbbVie’s portfolio. This role serves as an expert in the development, validation, transfer, and troubleshooting of immunoassays and in vitro cell-based models (including immunogenicity prediction tools, drug safety assessment tools, assessing biomarkers and others as needed) to support AbbVie’s biologic therapeutics portfolio- specific to ocular and aesthetics. This individual should be proactive, inquisitive and a self-starter who is eager to learn and thrives in fast paced environment.
The ideal candidate will have pharmaceutical industry experience in the development of biologics. Candidates ideally have hand-on laboratory experience as a contributor working in the capacity of biologics drug development. Ideally, this individual will have knowledge of relevant global health authority guidelines and industry practices. Candidates should have experience in working in a matrix team environment as a project team representative. Excellent communication practiced through oral, written and presentation skills is required.
KEY DUTIES AND RESPONSIBILITIES: Describe scope:
% of Time or
Development of Immunology in vitro models to support AbbVie’s biologic therapeutics portfolio
Project team support/ representation.
Process Improvement and Training
Education and Experience
- 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) and a minimum of 4+ years relevant industry experience. M.S with relevant experience of 10years will also be considered.
- Hands-on laboratory experiences with basic immunology models using hu iPSC derived 3D organoids, organ on a chipand primary cells using assays (flow cytometry, ligand binding assay such as ELISA/ELISPOT, cellular biomarker and translational assays, and primary cell isolation and culture) are preferred.
- Knowledge in basic cell biology, immunology or pharmacology space.
- 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.
- Experience with biologics projects is required.
- Experience with guidelines that are used in GLP/GCP compliant environment.
- 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.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
- Develop and execute robust bioanalytical and in vitro models to support studies. These assays will focus initially on immunogenicity risk assessments, target engagement, assess immunogenicity, tolerability, and exposure of the drug candidates.
- Work closely with immunoassays, cell culture, ex-vivo assays using hu iPSC derived 3D organoids/organ on a chip/ primary cell to contribute to assess drug safety effects and activities related to the immune response for ocular therapeutics and aesthetics.
- 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
- Project team representation.
- Experience with relevant technology such as FACS/Singulex/Quanterix/MSD/Luminex/Gyros/ ELISA, qPCR, supporting nonclinical and clinical studies.
- Provide scientific oversight to contracted regulated clinical and nonclinical bioanalyses.
- Develop close and effective partnerships with other nonclinical and clinical pharmacologist, Toxicologists, research scientists, clinical developmental scientists, and project teams to foster a collaborative work environment.
- Complete projects and prepare reports appropriate for corporate and regulatory agencies within agreed timelines. Prepare presentations and represent Immunology internally and externally.
- Assist, train or supervise 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.
- Maintain awareness of current developments in the field through comprehensive reading of the literature and attendance at appropriate scientific meetings.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced