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Senior Scientist, Process Development and Optimization

2 months ago

Framingham Massachusetts, United States Replimune, Inc. Full time

Job Summary:

We are seeking a highly skilled Senior Scientist, Process Development and Optimization to join our team at Replimune, Inc. in Framingham. As a key member of our Process Development team, you will be responsible for leading drug substance process development lab-based process characterization and optimization activities and personnel in support of commercialization.

Key Responsibilities:

  • Design, develop, and optimize upstream processes for adherent cell cultures in bioreactors, focusing on scalability, reproducibility, and efficiency.
  • Provide deep technical expertise in cell culture biology, including metabolic pathways, nutrient utilization, cell growth, and virus replicating kinetics.
  • Lead process development characterization/optimization experiments to ensure successful execution to plan (upstream and downstream).
  • Design process development lab-based experiments to support process characterization/optimization.
  • Author/review protocols, reports, risk assessments, SOPs, and batch records.
  • Author/review sections of applicable regulatory filings (e.g., process characterization, process control strategy, etc.).
  • Optimize and execute robust bench and pilot-scale process steps, including cell build, production bioreactor, and purification techniques such as filtration and chromatography.
  • Collaborate with manufacturing, QA, F&E, and other process development personnel to support and improve process steps within the production process.
  • Ensure effective, high-quality, timely, and appropriate documentation in laboratory notebooks.
  • Co-supervise more junior lab-based staff.

Requirements:

  • Master's degree in an applicable field (chemical engineering, biology, etc.) and 4 to 6 years of related work experience.
  • OR Bachelor's degree in an applicable field (chemical engineering, biology, etc.) and 6 to 8 years of related work experience.
  • Hands-on experience in a biologics process development laboratory setting.
  • Prior experience as a people manager.
  • Demonstrated ability to work in cross-functional teams across the business.
  • Strong organizational skills and attention to detail.
  • Excellent written and oral communication skills and strong team player.