Vertex Pharmaceuticals
Analytical Development Senior Research Associate, Cell & Gene Therapy
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
Analytical Development Senior Research Associate, Cell & Gene Therapy
General Summary:Vertex Pharmaceuticals is seeking a Senior Research Associate to join our analytical development team in the Cell and Gene Therapy organization. This position is expected to provide 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. Hands-on experience is preferred in 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 can work with data scientists in data interpretation.Key Responsibilities:Support the execution of molecular assay development projects for cell or gene therapy products.Design, develop, qualify, and transfer novel molecular assay methods to QC.Support development of novel molecular assays for the characterization of cell-based products at DNA and RNA levels.Independently analyze acquired 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.Experienced with statistical analysis and data visualization tools, such as JMP, GraphPad, R.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:M.S. (or equivalent) with 1+ years' relevant experience in biopharmaceutical industry.B.S. (or equivalent) with 3+ 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.Company Information:Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
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General Summary:Vertex Pharmaceuticals is seeking a Senior Research Associate to join our analytical development team in the Cell and Gene Therapy organization. This position is expected to provide 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. Hands-on experience is preferred in 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 can work with data scientists in data interpretation.Key Responsibilities:Support the execution of molecular assay development projects for cell or gene therapy products.Design, develop, qualify, and transfer novel molecular assay methods to QC.Support development of novel molecular assays for the characterization of cell-based products at DNA and RNA levels.Independently analyze acquired 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.Experienced with statistical analysis and data visualization tools, such as JMP, GraphPad, R.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:M.S. (or equivalent) with 1+ years' relevant experience in biopharmaceutical industry.B.S. (or equivalent) with 3+ 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.Company Information:Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
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