Adaptimmune is now at the forefront of transforming immunotherapy and developing a broad pipeline of optimized engineered T-cell therapies to treat cancer and other serious conditions.
Ability to work flexible shift including Saturdays.
We are looking at hiring for two shifts:
8am-4pm and 1pm-9pm
Performs cell manufacturing related activities while wearing clean room attire in an aseptic cGMP manner.
Documents production operations in corresponding batch records and logbooks 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 logbooks.
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.
Supports facility GMP compliance activities.
Support training and safety initiatives including any applicable GMP requirements for working in area.
Handles human blood and human blood-based product intermediates.
May train peers and other manufacturing employees in manufacturing process
Helps with warehouse management, critical reagents and material inventory reports.
Bachelor degree (preferred) in a cell biology, chemical engineering, bioengineering or medical technology related field, or equivalent experience is required with a minimum of 2 years of manufacturing or pharmaceutical/Biotech aseptic processing experience.
3 to 5 years' experience is preferred in a GMP setting
Experience in a cGMP environment, or pharma / biotech manufacturing environment is preferred with focus on aseptic technique and tissue culture skills.
Aseptic/ sterile techniques and prior experience working in a cGMP environment is preferred
Assists in the day to day manufacturing operations, and identifies improvement opportunities
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 complete assigned tasks in a timely manner
Ability to resolve technical, material and cGMP problems that may impact project deadlines
Provides guidance and troubleshooting assistance as needed during a deviation in the process
Duties may require overtime work, including nights and weekends is required. Ability to stand for multiple hours and lift 20 pounds
Experience with working in an aseptic cleanroom with full aseptic gowning is a plus
Computer literacy including Microsoft Outlook, Word, Excel and Power Point
Adaptimmune Therapeutics Plc