Analytical Development Expert

1 day ago


Waltham, Massachusetts, United States Cedent Consulting Full time
About the Job:

We are seeking a highly skilled Principal Associate Scientist to join our team at Cedent Consulting. This is a contract position with an estimated salary of $120,000 - $150,000 per year, based on industry standards and location in Waltham, MA.

Key Responsibilities:
• Develop and optimize molecular assays for characterizing and testing viral vectors, cell, and gene therapy products.
• Collaborate with the Analytical Testing Core and QC team to create and refine protocols, reports, and technical documents.
• Troubleshoot 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.
• Present assay data during team meetings and collaborate effectively with internal teams and external vendors.

Requirements:
• Bachelor's degree in Cell Biology, Molecular Biology, Biochemistry, or related field with 6+ years of relevant experience, or Master's degree with 4+ years of experience in a biotech setting.
• Experience in analytical method development and qualification for 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 products and viral vectors 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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