Principal Associate Scientist (Analytical Development) (Waltham, MA)

• Execute, develop, and optimize molecular assays for characterizing and testing viral vectors (Lentiviral vector, AAV), cell, and gene therapy products, in collaboration with the Elevatebio Analytical Testing Core and QC team.
• Work with AD SMEs, Analytical Testing Core, and QC teams to create and refine protocols, reports, and other technical documents for method development and optimization.
• Troubleshoot and address challenges during qualification and method transfer activities with key stakeholders.
• Support assay development and lifecycle management, incorporating new ideas and technologies as needed.
• Assist in investigations related to deviations during assay qualification or validation.
• Analyze, interpret, and present assay data during team meetings.
• Collaborate effectively with internal teams in Analytical Development, Quality, and external vendors.

• BS in Cell Biology, Molecular Biology, Biochemistry, or related field with 6+ years of relevant experience, or MS with 4+ years of experience in a biotech setting.
• Experience in the development and qualification of analytical methods for QC GMP labs is preferred.
• Knowledge of ICH guidelines for method development/qualification is desirable.
• Expertise in molecular technologies such as ddPCR, qPCR, and ELISA.
• Familiarity with cell and gene therapy (CGT) products and viral vectors (Lentivirus, AAV) is a plus.
• Strong writing and communication skills, with experience in authoring and reviewing protocols and technical reports.
• Excellent organizational and multitasking abilities, with experience working in a cross-functional team environment.

This is a contract position