Overview

This position will become part of the newly formed Immunology Department. The mission of the Immunology Department is to develop and implement fit-for-purpose strategies and methodologies to monitor immune responses to company's therapeutics in vitro and in vivo; to understand the potential impact of immunogenicity on safety and efficacy; and when applicable, to develop and implement appropriate approaches to manage such immune responses with the goal to maximize patients' benefit. This role will interact and collaborate with multiple functions, including but not limited to Biomarkers, Product Development, Clinical Science and Operations, and CMC.

Responsibilities

• Perform standard in vitro immunogenicity assays using primary human cells evaluating adaptive T and B cell responses to company's AAV vectors and their transgenes.
• Establish functional assays using primary human NK cells, macrophages, and other effector cells of the innate immune system to investigate activating properties of 4DMT vectors.
• Implement innovative in vitro assays to measure complement and Pattern Recognition Receptors such as TLR2 & TLR9 activating properties of company's vectors.
• Develop and validate platforms such as 3D lymphoid organoids for assessing the immunogenic potential of AAV vectors and transgenes.
• Work closely with the Biomarker Group and contribute to high-priority work requiring assay development and molecular biology support.

• Identify and select CROs that will provide the best service in terms of technology, timeline, and cost for the study objectives.
• Develop immunogenicity study plans with CRO by writing SOWs and negotiating timelines and budgets.
• Monitor and review the progress of the study and provide regular updates to supervisor and stakeholders.
• Review, summarize and provide recommendations after the conclusion of the study to the supervisor and stakeholders.

• Act as liaison for the Immunology department in project team meetings and if deemed appropriate lead pre-clinical technology projects.
• Working with Immunology head, providing input on immunogenicity risk assessment and management in project leaders.
• Communicate to project leaders fit-for-purpose and stage-appropriate immunogenicity assessment strategies and approaches for preclinical and development projects.

Job Requirements

QUALIFICATIONS

• Ph.D. in Immunology with preferred specialization within innate immunology, viral immunology, or transplantation immunology
• Minimum of 2 years of direct experience in cellular immunology research within academia, biotech, or large pharma industry
• Experience in cell-based assay development - Preferred
• Familiar with bioinformatics - Preferred

SKILLS

• Expertise in the handling of human PBMC, isolation, and culture of T, B, and NK cells, monocytes, macrophage, and dendritic cells.
• High-level competency in flow cytometry, ELISpot, Luminex or equivalent, and co-culture activation techniques.
• Competency in basic molecular biology and biochemical techniques including PCR and ELISA.
• Strong statistical analysis and data interpretation skills.
• Able to manage multiple projects simultaneously and work in a team setting
• Good verbal and written communication skills
• During COVID-19 this person needs to be in a lab
• 2-3 days a week will be in the lab
• Adhere to company's Covid protocols and policy