Process Development Engineering Senior Scientist

Vertex Inc. • Boston, MA

1d • $123,200 - $184,800 • Onsite

About The Position

Vertex is seeking a Senior Scientist to join its Process Development team. The role leads process development and engineering studies for a cell-based drug candidate designed to treat diabetes, including internal process development, process robustness and characterization studies, and possible support for manufacturing investigations. The Senior Scientist leads a weekend-shift team to maintain continuity of ongoing studies over weekends and holidays. The position is full-time, Thursday through Monday, 8 a.m. to 5 p.m., and is designated on-site, with ad hoc flexibility.

The role involves developing robust manufacturing processes for cell therapy products and supporting implementation for programs in clinical development. It includes leading and training bioprocess associates and engineers, coordinating weekend coverage, managing or performing pluripotent stem cell culture and differentiation, troubleshooting complex issues, analyzing and documenting experimental results, and coordinating team resources and priorities. The Senior Scientist also collaborates across functions and contributes to technical reports, regulatory filings, source documents, patents, and external publications as applicable.

Requirements

• BS in Biochemistry, Engineering, Biology, or a related discipline with at least 8 years of industry experience; or an MS with at least 5 years of industry experience; or a PhD with 2–5 years of industry experience.
• At least 1 year of direct management experience.
• Willingness to maintain a weekend and holiday shift schedule.
• Experience independently conducting and directing the design, execution, analysis, and documentation of cell culture processes for biologics and/or cell therapy products.
• Experience with design of experiments (DOE) and statistical analysis.
• Experience working with cell-processing devices and bioreactors, such as stirred tank reactors, Unifuge Mini, ATFs, and Ambr250.
• Working knowledge of GMP requirements.
• Strong communication and collaboration skills, including experience managing changing priorities.
• Excellent verbal and written communication skills; ability to handle multiple tasks, meet timelines, and adapt to changing priorities.
• Strong organizational skills and high attention to detail.

Nice To Haves

• Pluripotent stem cell culture experience in 2D and/or 3D.

Responsibilities

• Design and execute experiments to develop robust manufacturing processes for cell therapy products and support implementation for programs in clinical development.
• Lead process robustness and characterization studies to support process understanding and clinical development goals.
• Lead and train the weekend-shift team of bioprocess associates and engineers.
• Develop reliable weekend coverage plans for ongoing studies by understanding experimental goals, creating schedules, and delegating work.
• Manage and/or execute pluripotent stem cell culture and differentiation for process development, optimization, and characterization.
• Manage complex troubleshooting.
• Document experimental procedures and results according to established guidelines.
• Perform statistical analysis of experimental data to determine critical process parameter ranges.
• Communicate progress against plans and escalate business-critical issues affecting supply and timelines, offering recommendations, mitigations, and potential solutions.
• Collaborate with departmental and cross-functional teams, contribute to deliverables, drive development activities, resolve issues, and lead integrated projects.
• Coordinate resources and set priorities for the team in support of departmental goals.
• Generate and review technical reports, regulatory filings, source documents, patents, and external publications, as applicable.

Benefits

• Annual bonus and annual equity awards; some roles may also be eligible for overtime pay in accordance with federal and state requirements.
• Medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the summer and winter.
• Educational assistance programs, including student loan repayment.
• Commuting subsidy.
• Matching charitable donations.
• 401(k).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior