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Sr. Process Development Specialist - Boston, MA
$72,800 - $83,200/Yr
Hydrogen Group - Boston, MA
posted 2 months ago
Full-time - Mid Level
Boston, MA
Administrative and Support Services
About the position
The Senior Process Development Specialist will play a pivotal role in the Cell Therapy Core & Process Development team, focusing on the development and production of high-quality media and cell therapy intermediates. This position is essential for supporting Cell and Gene Therapy projects, with responsibilities including overseeing stem cell culture processes and managing project timelines.
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.
- Oversee project timelines and deliverables, engage in complex troubleshooting, and perform Root Cause Analysis (RCA) as needed.
- Accurately record experimental methods and outcomes in compliance with set standards. Analyze experimental data statistically to identify trends and critical process parameters.
- Work cohesively with internal teams to support departmental objectives. Play an active role in a multidisciplinary setting to meet collective targets.
- 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.
