Sr. Cell Processing Associate

RoslinCT US•Hopkinton, MA

2d•$77,000 - $115,000•Onsite

About The Position

Reporting to the Manufacturing Supervisor, this position's core accountabilities 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 Sr. Cell Processing Associate will also collaborate as needed with peers within Manufacturing Sciences and Technology (MST), Quality and Facilities.

Requirements

4-6 years of experience with bachelor’s degree in biology or related scientific discipline, or equivalent combination of experience and education.
Prior experience with biopharmaceutical manufacturing; cell or gene therapy manufacturing
Knowledge of the Current Good Manufacturing Practices (cGMP's).
Excellent skills in Microsoft Word, Excel, and commonly used Manufacturing and Quality systems
Excellent technical writing and oral communication skills
Driven individual that works well independently and within cross-functional teams

Responsibilities

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
Work as part of a team and lead some deviation and root cause analysis in the event of any discrepancies that arise during processing.
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.
Ability to train and mentor junior personnel.
Escalate processing and equipment issues as needed.
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.
Daily review of in-process cGMP documentation for completeness and accuracy
Other duties as assigned by Supervisor or Manager