Job Description
You can get further details about the nature of this opening, and what is expected from applicants, by reading the below.
General Summary :
Vertex pharmaceuticals is seeking a senior research associate to join our analytical development team in 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 scientist in data interpretation.
Key responsibilities of the research scientist will include :
- 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.
Flex Designation : On-Site Designated
On-Site Designated
Flex Eligibility Status :
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
Note : The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
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.
Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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