Senior Research Associate (Assay Development and Manufacturing Associate) - Contract
About The Position
Join our innovative team dedicated to reducing cancer deaths through cutting-edge liquid biopsy diagnostics. As Sr. Research Associate, you will be responsible for performing functional quality control testing of incoming GMP-grade reagents, preparing manufacturing controls, and supporting our CLIA-certified laboratory operations. You will work with molecular and biochemical assays, utilizing automated liquid handling systems to ensure our manufacturing processes meet stringent quality standards. Additionally, you will support research and development activities as needed, contributing to method optimization and validation studies. This contract position requires strong attention to detail and the ability to work in a regulated GMP/CLIA environment where precision and documentation are critical.
Requirements
- BS with 3-4 years of experience, or MS with 2-3 years in relevant field (e.g., biomedical engineering, molecular biology, genetics, or genomics)
- Hands-on experience with automated liquid handling systems (Hamilton, Tecan, or similar platforms)
- Direct experience in a regulated environment (CLIA, CAP, FDA, GXP, etc.)
- Proficiency in high-throughput manual and automated laboratory techniques for molecular biology and biochemical assays
- Strong analytical skills with ability to independently design experiments, troubleshoot technical challenges, and interpret results using sound scientific reasoning
- Excellent technical writing capabilities for developing protocols, SOPs, and development reports
- Superior organizational and project management skills with meticulous documentation practices, strategic planning abilities, and keen attention to detail
- Demonstrated ability to work independently while communicating effectively with cross-functional teams
Nice To Haves
- Direct experience working in a CLIA-certified laboratory or GMP manufacturing environment and familiarity with FDA 21 CFR 820 and ISO 13485 quality system requirements
- Experience with method development, optimization, and validation studies with NGS assays
- Experience with inventory management and lot tracking systems (NetSuite or similar ERP systems)
- Understanding of contamination control requirements for laboratory environments
- Data analysis skills using Excel or statistical software packages
Responsibilities
- Perform functional and other quality control testing on incoming reagents for molecular and biochemical assays with meticulous attention to detail and adherence to high-quality standards.
- Execute reagent qualification protocols following established SOPs and manufacturing procedures
- Prepare manufacturing controls and reference standards
- Operate automated liquid handling systems (Hamilton or similar platforms) for high-throughput reagent testing
- Maintain comprehensive documentation in compliance with FDA 21 CFR 820, GMP requirements, and CLIA regulations
- Track reagent lot numbers, expiration dates, and qualification results in inventory management systems
- Design, execute, and troubleshoot moderate to complex laboratory experiments utilizing molecular biology techniques for Next-Generation Sequencing (NGS).Assist with method optimization and validation studies for assay and QC method developmentPerform guard banding, stability and other studies, and analytical characterization experimentsExecute experimental workflows to support product development activities
- Communicate effectively with Quality Assurance, Manufacturing, and R&D teams regarding reagent performance and study resultsParticipate in manufacturing operations while maintaining strict environmental controls for laboratory workSupport multidisciplinary project teams as needed
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What This Job Offers
Career Level
Mid Level
Industry
Ambulatory Health Care Services
Number of Employees
101-250 employees
