Proclinical is seeking a Post Doctoral Immunology Scientist for a top pharmaceutical company located in Irvine, CA.
This individual will apply his or her immunology expertise as it relates to immune response to therapeutics and in vitro assay development in support of our biologic's portfolio. This role serves as an expert in the development, validation, transfer, and troubleshooting of in vitro assays (including pharmacokinetic, immunogenicity prediction tools, immunogenicity assays, biomarkers and others as needed).
Must be eligible to work in the US.
Job Responsibilities:
- Develop and execute robust in vitro/ex-vivo tools to support studies. These studies will focus initially on immunogenicity prediction, detection, and quantitation of target protein, as well as determine immunogenicity and exposure of the drug candidates.
- Work closely with immunoassays, cell culture, ex-vivo assays, co-culture experiments with 3-D organoids to contribute to activities related to the immune response to therapeutics.
- Develop assays using PCR, qPCR, ELISA as per program needs.
- 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 as needed.
- Design and conduct experiments internally and at external bioanalytical labs and interpret results to evaluate and characterize drug-induced immunomodulation of novel therapeutics.
- 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 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.
Skills and Requirements:
- 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). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with our internal and applicable regulatory requirements. Our internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.
- Knowledge on guidelines that are used in GLP/GCP compliant environment.
- Hands-on laboratory experiences with basic immunology assays (using flow cytometry, ligand binding assay such as ELISA/ELISPOT, cellular assays, and primary cell isolation and 3-D organoid) are preferred.
- Experience with human PBMC; 3-D human/mouse organoids and primary cell-lines and co-culture techniques, are preferred.
- Experience with relevant single and multiplex technology such as Singulex/Quanterix/MSD/Luminex/Gyros/ ELISA, qPCR, and other cell-based assays supporting nonclinical and clinical studies, are preferred.
- 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.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at (+1) 267-428-7770 or m.raletz@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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