Process Dev Engineering Principal Scientific Associate

Process Dev Engineering Principal Scientific Associate

Location:

50 Northern Avenue, Boston, Massachusetts 02210

Openings: 1

Duties:

• Support the development of robust, scaled upstream or downstream production processes and methods for cell and gene therapy projects.
• Perform stem cell expansion and differentiation in bench-scale bioreactors to support media development and optimization using high-throughput bench scale systems (Ambr
  15/Ambr
  250).
• Development and documentation of protocols and technologies in support of upstream and downstream cell product development from clinical to commercial scale.
• Apply DoE/ QbD principles in process development and characterization, establishing process parameters, and contributing to CMC sections of regulatory filings.
• Transfer processes to internal manufacturing and CDMOs, providing documentation, training, and technical support to ensure successful scale-up and implementation in cGMP environments.
• Plan, execute, and document experiments and data analyses in support of process improvement.
• Draft study protocols and reports while ensuring data integrity.
• Contribute to technical reports, regulatory filings, source documents, patents, and external publications.
• Prepare data analysis and deliver technical presentations to both the internal and external stakeholders in the process development department.
• Utilize industry standard quality management tools (RCA, FMEA) to troubleshoot and continuously improve process issues.
• Collaborate with cross-functional teams to meet project deliverables by providing technical expertise from lab experiment results to enable data-driven decisions for key stakeholders.

Requirements:
Employer will accept a Master's degree in Biotechnology, Science, Engineering or a related field and 3 years of experience in the job offered or in Process Dev Engineering Principal Scientific Associate- related occupation. Alternatively, employer will accept a Bachelor's degree in Biotechnology, Science, Engineering or a related field and 5 years of experience in the job offered or in a Process Dev Engineering Principal Scientific Associate-related occupation.

Position requires demonstrable experience in the following:

• Experience in process development, optimization and characterization using DoE/ QbD approaches for cell therapy products in ongoing and future projects.
• Exceptional aseptic techniques and hands-on cell culture laboratory experience with stem cells and mammalian cells in bench or bioreactor systems.
• Experience with small-scale bioreactors with working knowledge of scale-up parameters and strategies.
• Hands-on experience with routine and product-specific cell culture assays, including cell counting, metabolite analysis, flow cytometry, morphology, ddPCR, nucleic acid and protein assays, stem cell isolations, electroporation and cell harvest methods.
• Experience in potency and efficacy assay development and execution to evaluate the product quality profile of cell therapy products.
• Experience with data analysis and statistical software including Graph Pad Prism, JMP, and Excel to support process optimization and cell culture studies
• Documentation and technical report writing to support research deliverables, regulatory filings and commercial milestones.
• Knowledge of cell therapy product profiles, including iPSC-derived cell therapy products, hematopoietic stem cells and other mammalian cells.
• Deep understanding of 2D/3D stem cell culture expansion and differentiation in high throughput cell culture systems.
• Experience transferring processes to internal manufacturing or CDMOs, including preparation of technical documentation, training, and technical support for cGMP implementation.
• Utilization of industry-standard quality management tools (RCA-FMEA) to troubleshoot process deviations and continuously improve the process.
• Strong molecular biology expertise with CRISPR/Cas9 genome editing technologies, including assay development to evaluate editing efficiency and therapeutic performance.

Rate of Pay: $106870.00 - $ 110900.00

Pay Range: $86,800 - $130,200

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…