Associate Scientist, Analytical Sciences & Quality Testing (ASQT)

Responsibilities (including but not limited to):

This is an exciting, hands-on laboratory opportunity in Lexington, MA for an Associate Scientist who is passionate about improving patient outcomes through high-quality science. In this role, you will play a critical part in advancing innovative biologic programs by leading the development, qualification, and execution of robust analytical methods that ensure product quality and reliability. You will collaborate closely with Process Development and Manufacturing teams, contributing high-impact data that supports key milestones and ultimately helps deliver life-changing therapies to patients, while also authoring technical protocols and reports that shape program success.

Success in this role requires a collaborative, patient-focused scientist with strong communication skills and a proven ability to work effectively across cross-functional teams in a dynamic environment. You bring a proactive, resourceful mindset and thrive in a fast-paced setting with evolving priorities, while maintaining a commitment to the highest quality standards. Flexibility in scheduling is important to support program needs and ensure seamless progress toward shared goals, making this an ideal opportunity for someone energized by meaningful work and driven to make a real impact.

This is a five-day-per-week, on-site role, as we believe in-person collaboration is key to driving high-quality science and strong team connection.

This role reports to the Director, ASQT

Standout Skills for Impact:

• Execute analytical testing for GMP and non-GMP release and stability samples to support critical development and manufacturing timelines.
• Adhere to Good Manufacturing Practices by completing and maintaining accurate cGMP documentation (electronic and hard copy) for all work performed.
• Support daily laboratory operations, including reagent preparation and routine instrument calibration.
• Maintain laboratory reagent and materials inventory; initiate ordering as needed to ensure uninterrupted operations.
• Support GMP data review and compliance checks, including data scanning and trend analysis.
• Contribute to method qualification activities for analytical methods used by internal teams and external contract testing laboratories, helping ensure reliable, phase-appropriate assay performance.
• Author, review, revise, and execute technical protocols, reports, test methods, and SOPs that support efficient laboratory operations and regulatory readiness.
• Assist in coordinating sample management activities, including shipment, receipt, log-in, and inventory control.
• Help foster a safe, organized, and compliant laboratory environment by proactively identifying and addressing potential safety hazards.

Qualifications and Experience:
Bachelor’s degree in life sciences with a minimum of 3+ years of experience, or M.S. with 1+ year of experience, in analytical development and quality control within the pharmaceutical or biotechnology industry to include:

• GMP regulated environment
• LIMS systems to support sample tracking, data integrity, and laboratory workflows and laboratory software including SoloVPE (Viper), Empower, Compass, and SoftMax for routine testing and data analysis.
• Protein analytical techniques, including SoloVPE, icIEF, CE-SDS, and ELISA plate-based methods. HPLC-SEC, peptide mapping, and N-glycan analysis preferred.
• Demonstrated ability to execute core analytical development and quality control duties, including routine testing, data analysis, documentation, and supporting cross-functional program deliverables.