Research Associate II - Immunology

Position Summary

The Research Associate II – Blood Processing/ELISPOT, is one of the key laboratory members who will have an opportunity to learn and contribute to the understanding of AAV Immunogenicity by performing analyses on clinical study samples using immunological assays in support of our gene therapy programs.

Job Responsibilities

• Perform routine processing of whole blood samples from clinical studies.
• Cook up with Clinical team and/or Immunology lab manager for sample receiving, sample processing, testing and biobanking.
• Execute clinical immunoassays and other cell-based assays under the guidance of supervisor and/or lab manager.
• Perform data analysis and report the results accurately.
• Contribute to drafting of reports and presentations for technical discussions and/ or investigations with internal and external stakeholders.
• Contribute to assay development of new clinical assays which may include the optimization, qualification, validation, and troubleshooting of new analytical methods.
• Maintain a laboratory notebook or binder with worksheets recording details of performed experiments according to good documentation practices.
• Aid in maintaining a compliant GxP lab environment and adhere to GLP/GcLP guidelines.
• Aid in the maintenance of inventories and advise on reagents/supplies needed for the assigned projects for timely execution of related lab work.
• Provide support as needed to report results and discuss data.
• Author or contribute to standard operating procedures (SOPs) for new assay protocols and use of new laboratory equipment.
• Maintain flexible work hours and availability to accommodate off-hour sample arrivals with advance notice.

Minimum Requirements

• Bachelor's + 2 Years Experience or Master's + 0 Years of Experience or 6 Years Role Relevant Work Experience.
• Must possess intermediate lab skills in cell biology, cell culture, immunology, reagent preparation, and adherence to biosafety and chemical use guidelines.
• Familiarity with handling and working with human clinical lab samples.
• Familiarity with GCP/GLP/GxP lab standards and practices.
• Familiarity with LIMS.
• Must possess basic office skills using a PC and working with MS office tools (Word, Excel and PowerPoint).
• Must be self-motivated, organized, capable of working independently as well as a team contributor.
• Must possess strong oral and written communication skills, particularly in writing technical documents such as SOPs, assay validation plans, reports and clinical sample testing plans and reports.
• Excellent interpersonal skills with the ability to interact effectively with teams, internally and externally.
• Can work independently with minimal supervision under direct/remote management, but also work collaboratively with a broader team and across functional departments.
• Ability to perform light to moderate physical tasks for routine lab maintenance.

Preferred Education, Experience And Skills

• Experience in immunoassays such as ELISA, ELISPOT/FluoroSpot, neutralizing antibody, MSD, cytokine release and flow cytometry strongly preferred.
• Previous experience with handling clinical lab samples and blood processing workflow preferred.
• Experience with LabVantage LIMS preferred.
• Familiarity with statistical analysis preferred.
• Flexible schedule to accommodate real-time and urgent sample analysis preferred. May include weekend, holiday and after-hour availability.