Cell Processing Associate
RoslinCT
Summary
Reporting to the Manufacturing Supervisor, this position's core responsibilities are focused on manufacturing processes related to cell therapies. Activities include aseptic sampling of product in a Biosafety Cabinet (BSC) in an ISO V environment, operation of incubators in an ISO VII environment, as well operating automated, single-use systems for the targeting, expansion and harvesting of cells. The Cell Processing Associate will also collaborate as needed with peers within Manufacturing Sciences and Technology (MST), Quality and Facilities.
Job description
How You Will Make an Impact
- Assist with daily activities of a new cGMP facility by collaborating with Validation, MST, Facilities and Quality departments
- Perform manufacturing processes on the floor, following validation protocols, batch records and standard operating procedures (SOPs) to ensure safe and compliant operations
- Perform daily aseptic sampling for cell count, viability and other parameters
- Perform Equipment and Cleanroom cleaning activities in accordance with established procedures and schedule
- Work as part of a team to execute engineering and GMP runs in close collaboration with MST and operations
- Assist peers with deviations and root cause analysis in the event of any discrepancies that arise during processing
- As part of a team, process clinical material in automated systems as part of selection, expansion harvest and wash of cells in single-use systems
- Adhere to SOPs and cGMP regulations and accurately complete documentation associated with clinical manufacturing
- Escalate processing and equipment issues as needed
- Daily review of in-process cGMP documentation for completeness and accuracy
- Other duties as assigned by Supervisor or Manager
What You Will Bring
- A highly organized work style that ensures timely execution of tasks
- A mindset that ensures accurate results
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint)
- Effective problem-solving capabilities
- Strong oral and written communication skills
Qualifications
- 0-2 years of experience with Bachelor's degree in biology or related scientific discipline, or equivalent combination of experience and education
- Excellent skills in Microsoft Word, Excel, and commonly used Manufacturing and Quality systems
- Comfortable in a fast-paced and dynamic environment with minimal direction and able to adjust workload based upon changing priorities
Requirements
- 0-2 years of experience
- Bachelor's degree in biology or related scientific discipline, or equivalent combination of experience and education
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint)
- Excellent skills in Microsoft Word, Excel, and commonly used Manufacturing and Quality systems
- Effective problem-solving capabilities
- Strong oral and written communication skills
- Highly organized work style
- Comfortable in a fast-paced and dynamic environment with minimal direction
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Educational Assistance
- 401(k)
- Work-Life Balance
- Professional Development
Company overview
RoslinCT is a leading global contract development and manufacturing organization (CDMO) specializing in advanced cell and gene therapies. Founded in 2005 as a spin-out from the renowned Roslin Institute, the company builds upon the groundbreaking scientific legacy that produced Dolly the Sheep, the world's first cloned mammal. With dual headquarters in Edinburgh, Scotland and Hopkinton, Massachusetts, RoslinCT operates 22 purpose-built cGMP cell therapy processing suites across both locations. The company provides comprehensive CDMO services including process and analytical development, cGMP clinical and commercial manufacturing for both autologous and allogeneic cell therapies, iPSC cell line development, gene editing, and differentiation. RoslinCT has achieved significant industry milestones, including being among the first to produce clinical-grade human pluripotent stem cells and advancing the first CRISPR-edited stem cell-based therapy to marketing authorization. The company partners with biotechnology and pharmaceutical companies worldwide to accelerate the development and commercialization of life-saving cell and gene therapies, with a strong focus on quality, innovation, and patient impact.