Cell Processing Associate
About The Position
RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science. Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients. 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.
Requirements
- 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.
- 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
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
101-250 employees
