Demo

Principal Associate Scientist (Analytical Development)

CEDENT
Waltham, MA Full Time
POSTED ON 1/14/2025
AVAILABLE BEFORE 4/7/2025

Responsibilities :

  • 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.

Learn more about the general tasks related to this opportunity below, as well as required skills.

Required Qualifications :

  • 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.
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