Cell Processing Associate I, GMP Biotech Manufacturing

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

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.