Bachelor's degree in a related field with 5+ years of experience, or Master's degree with 2+ years, or High School Diploma with 9+ years of experience
Advanced lab skills in cell biology, cell culture, and immunology
Familiarity with handling human clinical lab samples
Knowledge of GCP/GLP/GxP standards
Flexible schedule for urgent sample analysis, including weekends and holidays
Strong communication skills for technical documentation
Ability to work independently and collaboratively across teams
Responsibilities
Perform complex assays independently
Develop and validate new clinical assays, including optimization and troubleshooting
Analyze data and interpret results accurately
Prepare validation reports and summaries
Coordinate sample receiving and testing with clinical teams
Participate in meetings to report results and address program needs
Maintain a compliant GxP lab environment and adhere to GLP/GcLP guidelines
Author SOPs for new assay protocols and equipment use
Maintain detailed laboratory records according to good documentation practices
Train and mentor junior lab members
Benefits
Full-time on-site role in Philadelphia, PA
Opportunity to build experience in Cell Biology and Immunology
Involvement in gene therapy programs
Mentorship opportunities within the lab
Collaborative work environment with clinical teams
Full Job Description
Position Summary
The Senior Research Associate, Immunology is one of the key laboratory members who will have an opportunity to contribute to the understanding of AAV Immunogenicity by performing analyses on clinical study samples using immunological assays in support of our gene therapy programs. The Senior Research Associate will contribute to activities in the lab to drive assay development and validation, real-time immune assessments of clinical studies, as well as clinical sample coordination and management. This is an excellent opportunity for a candidate who is looking to build his/her experience in Cell Biology and Immunology lab skills as they transition to a larger role in developing, validating and performing more complex assays associated with gene therapy to advance clinical programs.
Reporting to the Senior Director of Immunology, this position is a full-time on-site role located in Philadelphia, PA.
Job Responsibilities
Performance of complex assays without supervision
Perform assay development of new clinical assays which may include the optimization, qualification, validation, and troubleshooting of new analytical methods
Perform data analysis and interpret the results accurately
Preparation of validation reports and summaries
Coordinate with Clinical team and/or Immunology lab manager for sample receiving and testing
Participate in team and clinical program meetings as needed to report results, discuss data and address program needs
Build and maintain a compliant GxP lab environment and adhere to GLP/GcLP guidelines
Author standard operating procedures (SOPs) for new assay protocols and use of new laboratory equipment
Maintain a laboratory notebook or binder with worksheets recording details of performed experiments according to good documentation practices
Train and mentor Research Associates, contractors, and junior members of the laboratory
Minimum Requirements
Bachelor's degree in a related field with 5+ years of experience; or Master's degree in a related field with 2+ years of experience; or High School Diploma with 9+ years of experience
Advanced 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
Flexible schedule to accommodate real-time and urgent sample analysis; May include weekend, holiday and after-hours availability
Advanced 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
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
Ability to work independently with minimal supervision under direct/remote management but also work collaboratively with a broader team and across functional departments
Preferred Education, Experience and Skills
Experience in immunoassays such as ELISA, ELISPOT/FluoroSpot, neutralizing antibody, MSD, cytokine release and flow cytometry
Previous experience with handling clinical lab samples and blood processing workflow
