Process Development Research Associate (Contract)

Vertex Pharmaceuticals; Boston (MA); On-site; Full time

Job summary

An established industry player is seeking a motivated Process Development Scientific Associate to join their dynamic team in Boston. This role focuses on optimizing cell-based bioreactor processes for innovative cell and gene therapies. You will be pivotal in executing experiments, managing pluripotent stem cell culture, and collaborating with cross-functional teams to enhance manufacturing processes. If you are passionate about making a significant impact in the biotech field and thrive in a fast-paced environment, this opportunity is perfect for you. Join a forward-thinking company dedicated to transforming patient care through cutting-edge therapies.

Qualifications

• 0+ years of industry experience in cell culture and process development.
• Ability to execute and document cell culture processes independently.

Responsibilities

• Develop robust manufacturing processes for cell therapy products.
• Document experimental procedures and perform statistical analysis.

Skills

Cell Culture Techniques

Process Development

Statistical Analysis

Troubleshooting

Communication Skills

Organizational Skills

Education

BS in Biochemistry

BS in Engineering

BS in Biology

Tools

Bioreactors

Cell Processing Devices

Job description

Job Description

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 treat—and even cure—several of the diseases Vertex is focused on, including sickle cell disease and type 1 diabetes. Further investment in a research site to advance these programs will be essential to Vertex’s 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 cutting-edge 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 cell-based 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 Vertex's mission to bring innovative therapies to patients.

The Process Development group offers a dynamic and challenging environment, perfect for individuals who thrive in fast-paced, high-energy 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 cell-based products and combination products. This lab-based role focuses on 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 T-flasks 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 cross-functional 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).
• Coordinate resources and set priorities for own team, contributing to the department's overall goals.

Requirements:

• BS in Biochemistry, Engineering, Biology, or related discipline 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.

Pay Range: $32/hr - $35/hr