The Role:
The Associate II of the Analytical Testing Core is responsible for performing 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 transfer pre-qualified assay into the Analytical Testing Core for routine use. Once transferred, the associate will receive, prepare, and test samples per the established test method. Upon testing completion, the associate will ensure the timely review and reporting of data to the submitting group.

Here’s What You’ll Do:

• Work with management to implement laboratory systems to manage sample receipt, test execution, data integrity, and reporting.
• Draft SOPs, forms, and test records for the methods and equipment used in the Analytical Testing Core
• Implement test methods developed and pre-qualified in Analytical Development for routine non-GMP testing.
• Perform daily laboratory operations, including routine testing, inventory management, reagent ordering, and maintenance activities.
• Communicate with management and cross-functional stakeholders to ensure all testing is initiated and completed within required project timelines.
• Maintain control charts to monitor the performance of methods within Analytical Testing Core laboratory.

Requirements:

• Bachelor's degree with 1-3 years of experience in a technical discipline (Biology/ Chemistry/ Microbiology or related field).
• Experience working in an Analytical Development or Quality Control
• Experience with gene and cell therapy test methodologies (cell culture, Flow Cytometry, ELISA, ddPCR, and cell-based assays)
• Preferred: experience with biochemical and biophysical test methodologies like ELISA, U/HPLC, CE-SDS, etc.
• Ability to work in a collaborative team environment to meet project goals and testing turnaround times.
• Strong communication skills with an ability to clearly present complex scientific concepts and data.
• 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 lab-based role. May require evening and weekend work to support business goals.