What are the responsibilities and job description for the Principal Associate Scientist (Analytical Development) (Waltham, MA) position at CEDENT?
Responsibilities:
Required Qualifications:
- 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.
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.
This is a contract position
