Process Development Senior Research Associate Contractor

Vertex has established a new research site in Boston Seaport where research development and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treatand even cureseveral of the

Diseases Vertex is focused on include sickle cell disease and type 1 diabetes. Further investment in a research site to advance these programs will be essential to Vertexs continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT): our teams will bring together the best biology technologies and enhanced manufacturing capabilities to ensure we bring these cuttingedge transformative therapies to patients as quickly as possible.

General Summary:

Vertex seeks a highly skilled individual to join our Process Development team as a temporary worker. In this pivotal role you will spearhead process development/engineering activities for drug substance processes for one of our crucial cell and gene therapy assets. As a research associate you will play a significant part in our internal process development work optimizing cellbased bioreactor processes to enhance robustness decrease aseptic risk increase yields and reduce the cost of goods. Your contributions may extend to process characterization and technology transfer of manufacturing processes. Based in our Boston MA facilities this position offers a unique opportunity to substantially impact Vertexs mission to bring innovative therapies to patients.

The Process Development group offers a dynamic and challenging environment perfect for individuals who thrive in fastpaced highenergy settings. The ideal candidate will be a subject matter expert in process engineering or relevant fields with a solid technical operations background.

The Process Dev Engineering Scientific Associate will be part of a team responsible for process development and optimization and the optimization and characterization of cellbased products and combination products. This labbased role focuses mammalian cell culture in flasks and bioreactors for cell therapy programs.

Project Description: Pluripotent stem cell culture and differentiation support process development. The researcher conducts experiments documents results and contributes to team discussions. The researcher utilizes cell biology techniques and statistical principles to support process improvement. The researcher works with bioreactors spinners and Tflasks to pass and expand stem cells.

Key Responsibilities:

• Execute experiments to develop robust manufacturing processes for cell therapy products and implement them to support clinical development programs. Manage and execute pluripotent stem cell culture and differentiation to support process development optimization and characterization.
• Manage troubleshooting with a high degree of complexity.
• Document experimental procedures and results according to established guidelines. Perform statistical analysis of experimental data to determine critical process parameter ranges.
• Collaborate effectively within departmental teams and contribute to deliverables in a crossfunctional environment
• Ability to run and design an experiment related to cell therapy with the goal of process improvement: cell passaging and expansion in 2D(adhesion) and 3D(suspension).

• • Experience with bioreactors and the associated equipment and devices such as centrifugation and filtration.
  • Experience with directed differentiation of stem cell culture preferred.

• Coordinate resources and set priorities for own team contributing to the departments overall goals.
• Must be skilled in the Windows operating system and Microsoft Office including Word Excel and PowerPoint. Experience with electronic lab notebook and data management preferred.

Requirements:

• BS in Biochemistry Engineering Biology or related discipline with 3 years of industry experience; an MS with 0 years of industry experience
• Able to independently execute analyze and document cell culture processes for biologics and cell therapy products.
• Experience working with cell processing devices and bioreactors.
• Working knowledge of GMP requirements.
• Excellent verbal and written communication skills and ability to handle multiple tasks while meeting timelines and adapting to changing priorities.
• Strong organizational skills and high attention to detail.
• Weekend work to support cell culture activities will be required.

$43$47/HR

This job posting is for a temporary role with a thirdparty agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the thirdparty agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other jobrelated factors permitted by law. In addition this role will be eligible for overtime pay in accordance with federal and state requirements

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