Process Development Engineering Scientist

Vertex Pharmaceuticals LLC

Boston (MA)

Hybrid

USD 104,000 - 156,000

Full time

5 days ago
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Job summary

Vertex Pharmaceuticals LLC in Boston, MA seeks a Process Development Engineering Scientist to lead design and execution of cell-based process development studies, focusing on cell banking and hESC expansion, using QbD principles to build process understanding.

The role requires strong analytical skills, experience in biopharma development, and collaboration across teams, with emphasis on data integrity, documentation, and mentoring in a fast-paced environment.

Qualifications

  • Experience designing and executing process development studies in biopharma.
  • Knowledge of GMP and QbD principles.
  • Experience with cell culture process development and hESC expansion is preferred.
  • Ability to communicate results and write technical reports.

Responsibilities

  • Lead design, execution, and interpretation of process development studies focused on cell banking and hESC expansion.
  • Apply QbD to build process understanding and parameters.
  • Collaborate across functions for material planning, sampling, and execution planning.
  • Document data and support technology transfers and regulatory filings.

Skills

DOE methods
Statistical analysis
Scientific writing
Cross-functional collaboration

Education

Bachelor's degree in a relevant field
Master's degree in a related field
PhD in a relevant field

Job description

## Process Development Engineering ScientistApply: Boston, MA: Full time: Posted Today: REQ-30155**Job Description****General Summary:**Vertex is seeking a talented individual to join our CGT Process Development team as a Scientist. The primary focus of this role is to lead the design and execution of process development studies for a cell-based drug candidate designed to treat diabetes. The Scientist will provide scientific and technical rigor in study design, execution, and data analysis and leveraging innovative technologies to deliver robust cell banking and hESC expansion processes. The ideal candidate has experience and understanding of embryonic stem cell biology and cell culture platforms. This is a full-time position based in our Boston, MA facilities.**Key Duties and Responsibilities:*** Design, execute, analyze, and interpret studies supporting process development, optimization, robustness, and characterization activities with a focus on cell banking and hESC expansion.* Apply scientific, engineering, and Quality by Design (QbD) principles to build process understanding, establish process parameters.* Evaluate and implement novel technologies that advance process and project strategy.* Troubleshoot process challenges and contribute to manufacturing investigations using sound technical judgment and experimental data.* Clearly communicate experimental results, technical conclusions, and recommendations to project teams and stakeholders.* Ensure data integrity through timely completion of phase-appropriate documentation, including electronic lab notebooks, as well as authoring development protocols and technical reports to support technology transfers and regulatory filings.* Drive cross-functional alignment, including material planning, scheduling, sampling strategies, resource allocation, and execution planning, to ensure study readiness and timely delivery.* Lead team projects and provide mentorship, training and technical support to colleagues.**Knowledge and Skills:*** Demonstrated experience in process development, process engineering, or a related biopharmaceutical development environment with a working knowledge of GMP requirements.* Strong scientific foundation in study design, experimental execution, and data analysis, including experience with statistical principles and design of experiments (DOE).* Experience supporting cell culture process development, cell banking, and/or embryonic stem cell expansion desired.* Experience working with cell processing equipment such as stirred tank bioreactors, media exchange and harvesting technology [e.g., centrifuge, ATF] as well as automation [e.g., Ambr] is strongly preferred.* Proven ability to collaborate across technical and operational functions, coordinating study activities, materials, sampling strategies, and execution plans.* Strong written and verbal communication skills, including technical documentation, presentation of results, and clear explanation of complex scientific concepts.* Highly organized, accountable, and effective in a fast-paced, team-oriented environment.* Participate in weekend work rotation with the broader team.* Authorized to legally work in the US.**Education and Experience:*** Bachelor's degree in a relevant field is required* Bachelor's degree and 6+ years of experience or a Master's degree and 4+ years of experience or a PhD and 0-3 years of experience, or the equivalent combination of education and experience At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.**Pay Range:**$104,000 - $156,000**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Flex Designation:**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.
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