To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!

Pay Range - $45 to $50/hr. (negotiable)

Job Description:
Job Roles & Responsibilities:

What are the top 5 skills/requirements this person is required have?

• Required Skill 1: Cell-culture
• Required Skill 2: Immunoassays/Cell-based assays
• Required Skill 3: ELISA/Luminex
• Required Skill 4: : Work on experimental design, troubleshooting, assay optimization and data interpretation as needed.
• Required Skill 5: 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.
• What positions/background experience do you feel are successful in this role: PhD with 1 year of experience.

Summary:

• 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 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.

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.