Performs cell manufacturing related activities while wearing clean room attire in an aseptic cGMP manner.
Documents production operations in corresponding batch records and log books per established procedures ensuring accuracy and timely completion. Identifies real time manufacturing issues (deviations and atypical results) and communicates them to the Manufacturing Manager and the Quality team in a timely manner.
Responsible for drafting or modifying manufacturing documents with the Manager and Quality Team oversight. These documents include but are not limited to:
Copies of patient batch records and the Certificates of Analysis of the Drug Product.
SOPs and Batch Record versions.
Equipment and other log books.
Inputting and uploading of manufacturing data in real time to existing database.
Works with the Quality team to author out of specification (OOS) reports, deviation investigations and corrective and preventative actions.
Authors SOPs, batch records, validation plans and technical reports as assigned.
Performs validation and process development runs using cell therapy equipment including but not limited to elutriation systems, COBE 2991 Cell Wash Devices, CliniMACS and controlled rate freezer.
Handles human blood and human blood based product intermediates.
Trains peers and other manufacturing employees in manufacturing process.
Helps with warehouse management, critical reagents and material inventory reports.
Bachelor degree in a cell biology, bioengineering or medical technology related field, or equivalent experience is required.
A minimum of 1 year of laboratory or pharmaceutical/biotech aseptic processing experience is required. 3 to 5 years’ experience is preferred.
Experience in a cGMP environment, or pharma / biotech manufacturing environment is preferred with focus on aseptic technique and tissue culture skills.
Experience with Cell Therapy in a manufacturing, laboratory or academic setting is a plus.
Ability to work independently and in a team setting.
Ability to work flexible hours with some night and weekend availability is required. This is a start-up situation so schedules and shifts will change over time.
Ability to stand for multiple hours and lift 20 pounds.
Experience with working in an aseptic cleanroom with full aseptic gowning is a plus.
Excellent verbal and writing communication skills are required.
Computer literacy is required including Microsoft Outlook, Word, Excel and Power Point.