Production Associate I, Cell Base Therapies
Job Type
Full-time
Description

  

SCOPE: The individual will work under close supervision to conduct cGMP manufacturing of a cell-based product. This includes validation and development runs under cGMP and assistance in technology transfer of novel products. All activities will be performed in a cGMP-compliant environment


RESPONSIBILITIES:

  • Working closely with a supervisor execute procedures to manufacture cell therapy products ensuring that production batch records are completed at the highest standards according to Company policies and procedures.
  • Perform daily clean room activities such as equipment/material preparation and cleaning/sanitization of equipment and rooms including packaging and disposing of biohazard waste per established procedures. 
  • Assist in ordering and transfer of materials and maintain supplies adequate for production demands. Stocking of non lot controlled materials and cleanroom garments. 
  • Assist with execution of environmental monitoring of air, surfaces and personnel in classified areas. 
  • Provide assistance with authoring and revision of Batch records, SOPs, Temporary changes, Item Specifications and other cGMP documentation.
  • Perform other duties as required.
Requirements

  

  • Requires Associate Degree with 0-2 years’ experience. May have a Bachelors degree; however not required.
  • Experience with cell culture and/or molecular biology and aseptic techniques is strongly preferred.
  • Good communication skills to clearly convey complex information and ensure proactive communication in timely manner.
  • Must have strong computer skills.
  • Must be able to communicate effectively with co-workers and be willing to collaborate closely with co-workers and other groups
  • Must have initiative, high attention to detail, and the ability to multi-task
  • Flexibility with work schedules and duties including necessary extended hours, weekends and holidays.
  • Ability and willingness to be regularly, predictably, and reliably at work.