AskBio Inc. · 7 hours ago
Sr. Research Associate, CLIA Lab Immunology
Durham, NC
Full-time
Onsite
Senior Level
5+ years expAskBio Inc. is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The Senior Research Associate will develop and validate antibody assays to support gene therapy programs, ensuring compliance with regulatory standards and collaborating with cross-functional teams.
BiopharmaBiotechnologyHealth CareManufacturingMedicalMedical Device
Responsibilities
Develop, optimize, and validate immunoassays using various platforms (e.g., ELISA, MSD, flow cytometry, cell based)
Design and execute experiments to evaluate assay performance to meet FDA and CLIA guidelines
Implementing CLSI guidelines for assay development as needed
Optimize and troubleshoot experimental protocols to ensure accuracy, reproducibility, and efficiency
Preparation of validation plans in accordance with SOPs
Validate assays according to regulatory guidelines (e.g., FDA, ICH) and industry standards
Preparation of validation reports in close collaboration with QA team
Collaborate with cross-functional teams to ensure assay alignment with program goals
Analyze and interpret data including assay development and validation studies
Prepare and present data to project teams, management, and regulatory agencies
Perform clinical sample analysis and prepare comprehensive reports for clinical sites
Perform in-depth data analysis using advanced statistical and bioinformatics tools, and draw meaningful conclusions from the results
Evaluate assay-related data provided by the CRO and derive meaningful conclusions
Responsible for day-to-day operations and management of a clinical laboratory, ensuring that all procedures adhere to the standards set by the Clinical Laboratory Improvement Amendments (CLIA)
Manages the laboratory's inventory of equipment, reagents, and supplies. This includes coordinating maintenance, troubleshooting, calibration, and repair to ensure all instruments function correctly
Ensures the laboratory participates in and complies with an approved proficiency testing program. Review the results and ensure corrective action is taken for any unacceptable findings
Maintains thorough and accurate records for all laboratory activities, including quality control, maintenance, training, and corrective actions
Assists the lab director in preparing for inspections and internal or external audits from regulatory authorities
Upholds all federal, state, and local regulations and safety protocols, including CLIA and safety standards from agencies
Stay current with the latest advancements in gene therapy research and apply this knowledge to your work
Collaborate with colleagues to achieve project goals and timelines
Communicate effectively with team members, management, and external partners
Qualification
Required
Bachelor's degree in biological sciences, medical technology or related field with 5+ years of experience working in a high-complexity CLIA laboratory OR Master's degree in biological sciences, medical technology or related field with 2+ years' experience working in a high-complexity CLIA laboratory
Expertise with immunoassay techniques such as ELISA and cell-based assays
Experience designing, validating, and implementing new assays
Proficient in the operation and maintenance of immunoassay plate readers
Comprehensive understanding of CLIA, FDA, and other applicable regulations
Experience reviewing and evaluating quality control data and implementing corrective actions
Preferred
Total antibody assay, Cell based neutralizing antibody assay, MSD assay platform
Knowledge about CLSI guidelines
Company
AskBio Inc.
AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives.
501-1000 employees
H1B Sponsorship
AskBio Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (4)
2022 (8)
2021 (3)
2020 (3)
Funding
Current Stage
Late StageTotal Funding
$241.76MKey Investors
Scottish Enterprise
2020-10-26Acquired
2020-09-02Grant· $2.66M
2019-04-11Private Equity· $235M
Leadership Team
S
Samuel Hopkins
Sr. Vice President, Therapeutics
Mansuo L Shannon
Board Member
Recent News
Asklepios BioPharmaceutical, Inc. (AskBio)
2025-10-21
Company data provided by crunchbase