Sr. Specialist, Process Development
50 Northern Avenue, Boston, MA 02210 Boston, MA 02210 US
Job Description
Job Description
General Summary:
New research site in Boston Seaport where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat—and even cure—several of the Diseases is focused on include sickle cell disease, Duchenne muscular dystrophy, and type 1 diabetes. Further investment in a research site to advance these programs will be essential to continued and sustained leadership in these exciting approaches. At Cell and Genetic Therapies (CGT): our teams will bring together the best biology, technologies, and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.
General Summary:
Looking for a talented individual to join our team as a scientific specialist contractor in 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 the trends, 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:
· This role requires a high level of expertise in stem cell biology, process engineering, and project management, ensuring the successful development and implementation of cell therapy manufacturing processes.
· A 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 & filtration operation
· Flexibility: Availability for weekend work to maintain cell culture activities
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