The Role:

The Technical Lead is responsible for oversight of the day-to-day activities of the Analytical Testing Core, which performs non-GMP assays in support of the research, development, and manufacturing functions at our Basecamp facility in Waltham. This position will work with Analytical Development to train on and transfer pre-qualified assays into the Analytical Testing Core for routine use. Technical Lead will perform testing and analysis per the established test method, ensure the timely and accurate review and reporting of data to the submitting group, train Testing Core analysts on new assays as they become available, monitor control charts and assay performance, escalating any issues to promptly to management. This is a Tuesday-Saturday primarily lab-based role.

Here's What You'll Do:

• Act as subject matter expert for analytical methods within the Testing Core, with a high level of technical skill and thorough understanding of assay principles.
• Train on and implement test methods developed and pre-qualified in Analytical Development for routine non-GMP testing (including training of Testing Core staff).
• Collaborate with team members to align scheduling and training activities to maintain equitable workload.
• Perform daily laboratory operations, including testing, inventory management, reagent ordering, and maintenance activities.
• Thoroughly review and approve data according to assay acceptance criteria and be able to troubleshoot any testing excursions.
• Communicate with management and cross-functional stakeholders to ensure all testing is initiated and completed within required project timelines.
• Assist in implementation of laboratory systems to manage sample receipt, test execution, data integrity, and reporting.
• Draft SOPs, Test Methods, and forms for the methods and equipment used in the Analytical Testing Core.
• Maintain control charts to monitor the performance of methods within Analytical Testing Core laboratory.
• Support, train, and mentor Testing Core staff and direct reports.

Requirements:

• B. S. or M.S. in a technical discipline experience (Biology/ Chemistry/ Microbiology or related field) with 5 years in industry.
• Experience working in an Analytical Development or Quality Control.
• Hands-on experience with gene and cell therapy test methodologies including cell culture, Flow Cytometry, ELISA, MSD, ddPCR, and cell-based assays.
• Hands-on experience with Biophysical methods (HPLC, UPLC, AUC, Mass Photometry, CE) is a plus.
• Proven leader including experience managing at least 3 direct reports.
• Ability to work in a collaborative team environment to meet project goals and testing turnaround times, including evening and weekend work as needed.
• Strong oral and written communication skills with an ability to clearly present complex scientific concepts and data to a diverse audience.
• Excellent organization skills.
• Experience in cell and gene therapy manufacturing environment is a plus.
• Experience working with electronic systems (LIMS and ELN) is a plus.
• This is a full-time on-site Tuesday-Saturday lab-based role with managerial responsibilities.