Scientist III (Post-Doctoral Fellow, Immunology)

Scientist III (Post-Doctoral Fellow, Immunology)
Irvine, CA
12+ months initial contract
Hourly Pay Rate: $60-63/hr

Work with an industry leader in the Pharmaceutical industry! Orion Group is seeking a Scientist III to work with our client's research and development team in Irvine, CA.

The Immunology group in the Department of Local Delivery Translational Sciences is seeking a Post-doctoral Fellow, 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 in vitro assay development in support of our client's biologics 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).

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 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.

Qualifications:
* 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 internal and applicable regulatory requirements. internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

Preferred Skills and Experience:
* 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.

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.
* Cell-culture
* Immunoassays/Cell-based assays
* ELISA/Luminex
* Work on experimental design, troubleshooting, assay optimization and data interpretation as needed.
* Develop assays using PCR, qPCR, ELISA as per program needs.

What years of experience, education, and/or certification is required?
* Ph.D. in a discipline of biological sciences (i.e., Immunology, Biochemistry, Cell Biology, Bioanalytical or a related field)

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
* Hands-on laboratory experiences with basic immunology assays (using flow cytometry, ligand binding assay such as ELISA/ELISPOT, cellular assays, and 3-D organoid) are preferred.

Other notable details about the environment from the hiring manager about this role:
Dynamic work environment, ability to multi-task as needed.

What positions/background experience do you feel are successful in this role:
PhD with 1 year of experience.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.