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Cell Therapy Operator

2 months ago

pittsburgh, United States BlueSphere Bio Full time

BlueSphere is a Pittsburgh-based immunotherapy company developing novel T-cell therapies to treat individuals diagnosed with liquid and solid tumors. The established proprietary platform technologies in Neoantigen and tumor-specific TCR discoveries have provided a rich foundation for various TCR-T cell therapy pipelines and cancer vaccines to address unmet medical needs in both blood and solid tumors.

 

The Product Development (PD) organization at BlueSphere Bio aims to accelerate the translation of innovative research discoveries into new cancer therapeutic medicines through collaboration with CMC, clinical, and business development functions. 


Responsibilities

  • The Specialist will perform cell processing activities, media formulation, product sampling, and other manufacturing needs as necessary, commensurate with the employee's level of training and experience.
  • Work is primarily in Grade B and Grade C aseptic manufacturing environments but may also include support of process development runs in the Manufacturing Science and Technology Laboratory.
  • Performs cell manufacturing-related activities while wearing clean room attire in an aseptic cGMP manner
  • SME on unit operations
  • 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 Manufacturing Management and the Quality team promptly
  • Inputting and uploading manufacturing data in real-time to an existing database
  • Works with the Quality team to author out-of-specification (OOS) reports, deviation investigations, and corrective and preventative actions.
  • Authors or edit SOPs, batch records, training records, logbooks, validation plans, and technical reports as assigned
  • Handles human blood and human blood-based product intermediates; Helps with warehouse management, critical reagents, and material inventory reports
  • Review of Batch Records and logbooks/comment resolution
  • Work on project teams (continuous improvement initiatives)-
  • Train new or junior employees on equipment and unit operations
  • This is a start-up situation, so schedules and shifts will change over time


Qualification

  • Bachelor’s degree in cell biology, bioengineering, or medical technology-related field, or equivalent experience is required
  • Ability to work flexible hours with some night and weekend availability is required
  • Ability to stand for multiple hours and lift 20 pounds
  • Excellent verbal and written communication skills are required
  • Computer literacy is required, including Microsoft Outlook, Word, Excel and PowerPoint
  • 1+ years’ experience working within cGMP regulated environment, including Good Documentation Practices (GDP)
  • 1+ years’ experience with Mammalian Cell Culture