Cell Processing Associate I

RoslinCT US; Hopkinton (MA); On-site; USD 50,000 - 75,000; Full time

Job summary

RoslinCT is seeking a Cell Processing Associate to support manufacturing of cell therapies in a new cGMP facility. You will perform aseptic sampling, operate incubators, and run single-use automated systems under SOPs and cGMP guidelines.

Collaborate with MST, Quality and Facilities to execute GMP runs, document activities, and maintain cleanroom standards. Candidates with 0-2 years of biology-related education and proficiency in MS Office are encouraged to apply.

Qualifications

• 0-2 years of experience with Bachelor's degree in biology or related scientific discipline
• Excellent skills in Microsoft Word, Excel, and commonly used Manufacturing and Quality systems
• Fast-paced environment ability to adapt to 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

Skills

Organized work style

Attention to accuracy

Microsoft Office proficiency

Problem-solving

Strong communication skills

Education

Bachelor's degree in biology or related field

Tools

Manufacturing systems

Quality systems

Job description

WHO WE ARE

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.

THE ROSLINCT WAY

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.

ACCELERATING YOUR FUTURE

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.

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

OUR COMMITMENT

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

RoslinCT is proud to be an equal-opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.