Unclassified - Waltham, MA
posted 2 months ago
Full-time - Principal
Waltham, MA
About the position
The Principal Associate Scientist in Analytical Development is responsible for executing, developing, and optimizing molecular assays for characterizing and testing viral vectors and gene therapy products. This role involves collaboration with various teams to create and refine protocols, troubleshoot challenges, and support assay development throughout its lifecycle.
Responsibilities
- Execute, develop, and optimize molecular assays for characterizing and testing viral vectors and gene therapy products.
- Collaborate with Analytical Development SMEs, Analytical Testing Core, and QC teams to create and refine protocols, reports, and technical documents.
- 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.
Requirements
- 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.
