Our Vaccine client partnered with the NIH is looking to add a RA/Sr. RA, QC Analytical Development to their team in Woburn, MA. Associate will execute Quality Control testing and associated operations as well as develop analytical assays to support the current and future products. This is a unique opportunity to be part of an emerging startup bringing innovative technology to the global market.
• Executes experiments for developing analytical test methods for use in process development support and ultimately cGMP testing within timelines
• Understand cGMP assay qualification/ validation protocols and reports, and executes routine QC testing.
• Write and perform cGMP assays and SOPs, maintain cGMP laboratory equipment and documentation
• Familiar with protein characterization techniques such as HPLC, SEC, DLS, ELISA, SDS-PAGE, UV-Vis, and potency assays.
• Troubleshoot challenging technical, experimental, and instrumental issues
• Able to react to change productively and handle other essential tasks as assigned
• Contribute to experimental planning; analyze data, communicate results, and present work in team meetings
• Maintain an accurate and high standard for laboratory records, electronic lab notebook entries, including up-to-date data records
• Bachelor’s degree with 4 years of related experience or Master’s degree with at least 2 years of industrial experience in a related field.
• Hands-on experience in developing and executing methods for protein characterization
• Experience in immune-based assays, HPLC, SEC, DLS, SDS-PAGE, UV-Vis, and ELISA
• Experience working in a QC/GMP laboratory is a plus