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Sr. Process Development Specialist

2 months ago


Boston, United States Hydrogen Group Full time

Location: Boston, MA

Contract: 12-months

Pay rate: $35.00 - $40.00 per hour

We are looking for a talented individual to join our team as a Scientific Specialist Contractor in the Cell Therapy Core & Process Development team. In this key role, you'll lead the development and production of high-quality media and cell therapy intermediates, as well as drug products, to support our Cell and Gene Therapy projects. As a Senior Contractor, you'll be crucial in our process development, setting schedules, and maintaining embryonic stem cell culture processes.

Our Process Development group is dynamic and fast-paced, ideal for those who excel in energetic environments. We're seeking an expert in stem cells upstream processing or related fields, with a strong background in technical operations.

Key Responsibilities:

  • Oversee and perform routine stem cell culture, expansion, and differentiation of pluripotent stem cells to aid in process development, enhancement, and evaluation.
  • Establish and maintain laboratory capabilities for generating cell therapy process intermediates, as well as Drug Substance (DS) and Drug Product (DP) materials, adhering to predefined protocols.
  • Project Management: Oversee project timelines and deliverables, engage in complex troubleshooting, and perform Root Cause Analysis (RCA) as needed.
  • Documentation and Analysis: Accurately record experimental methods and outcomes in compliance with set standards. Analyze experimental data statistically to identify trends and critical process parameters.
  • Collaboration: Work cohesively with internal teams to support departmental objectives. Play an active role in a multidisciplinary setting to meet collective targets.
  • Resource Coordination: Allocate resources and establish priorities for the team, contributing significantly to the department's overarching objectives.

Requirements:

  • High level of expertise in stem cell biology, process engineering, and project management, ensuring the successful development and implementation of cell therapy manufacturing processes.
  • Bachelor's degree in Biochemistry, Engineering, Biology, or a related field with over 5 years of industry experience, or a Master's degree with over 3 years of experience.
  • Capable of designing and conducting cell therapy experiments for process enhancement, including routine cell passaging and expansion in both adherent and suspension cultures in bioreactors independently.
  • Hands-on experience in aseptic techniques, bioreactors, harvest, and filtration operation.
  • Flexibility: Availability for weekend work to maintain cell culture activities.

...