Job Description

General Summary:

Vertex pharmaceuticals is seeking a research scientist to join our analytical development team in cell and gene therapy organization. This position is expected to provide key technical expertise in developing molecular based assays to support process development, product characterization and product release for our C> pipelines. Our team is seeking experienced, innovative, and motivated candidates with strong hands-on experience in DNA&RNA based molecular assay development and qualifications. Extensive hands-on experience is required in the area of DNA and RNA sequencing, scRNA-seq, off target analysis, ddPCR, qPCR and multiplex molecular assay development. Experience is required in developing robust analytical methods, that can be qualified, validated and transferred to QC labs for product release and shelf-life testing. This candidate is expected to understand computational analysis of next generation sequencing and collaborate closely with data scientist and discovery scientist in data interpretation. A strong background in stem cell biology and iPSC differentiation biology is desired.

Key responsibilities of the research scientist will include:

• Lead the design and execution of molecular assay development projects for cell or gene therapy products
• Design, develop, qualify and transfer novel molecular assay methods to QC
• Develop new and novel molecular assays for the characterization of cell-based products at DNA and RNA levels.
• Independently analyze acquired genomic data, method development results, prepare reports and presentations.
• Execute test methods in support of Process Development activities (e.g. sequencing, ddPCR, qPCR etc)
• Troubleshoot, optimize, and trend assay performance.
• Report on project progress to multiple audiences including Sr. Management, contribute to study protocols and reports, provide technical recommendations to management.
• Maintain excellent written documentation of completed experiments (e.g. electronic lab notebook and study reports).
• Identify, qualify, and manage critical reagents according to regulatory standards.

Knowledge and Skills:

• Hands-on experience with several of the following analytical techniques: NGS, scRNA-seq, off target analysis, ddPCR, qPCR and multiplex molecular assays.
• Strong biological background in stem cell biology and iPSC cell differentiation.
• Ability to leverage literature to design proof of concept experiments for novel assays.
• Proven track record developing assays for the assessment of cell-based products including composition, impurities and contaminations employing multiple analytical methods.
• Excellent communication skills with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team.

Required qualifications:

• Ph.D. (or equivalent) in chemistry, biochemistry, molecular science or relevant field with 0-3 years' experience in biopharmaceutical industry.
• M.S. (or equivalent) with 4+ years' relevant experience in biopharmaceutical industry.
• B.S. (or equivalent) with 8+ years' relevant experience in biopharmaceutical industry.
• Experience in analytical CMC development for gene or cell therapies, or biologics products.
• Excellent problem-solving skills.
• Excellent communication skills to communicate across multiple functional areas.

#LI-SV1 #LI-onsite

Company Information