Scientist II, Immunology
Company: AbbVie
Location: Irvine
Posted on: August 4, 2022
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Job Description:
Scientist II, Immunology Summary 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. Responsibilities 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. Qualifications The successful
candidate is required to have Bachelor's degree or equivalent
education and typically 7years 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. 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. PDN-ABV2208954
Keywords: AbbVie, Irvine , Scientist II, Immunology, Healthcare , Irvine, California
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