Manufacturing Associate

Our Cell Therapy client in Houston, TX is growing and looking to add Manufacturing Associates to their Cell Therapy Technical Operations team!  These roles will be responsible for manufacturing cell therapy products under cGMP guidelines and supporting cellular therapeutic manufacturing operations for in-house manufacturing campaigns. Responsibilities will include process transfers, technology improvements, generation of batch records, process validation and related materials, documents, and reports associated with clinical trials and manufacturing of clinical product with high quality and timely output.

  • Work in a clean room environment according to cGMP regulations
  • Execute batch records and organize documentation associated with clinical manufacturing and development activities
  • Assist with technology transfers between laboratories
  • Review process and batch record documentation including, but not limited to, peer review
  • Assist with preparing data analysis and trending for process, stability and analytics
  • Support development of BPRs, SOP’s, WI’s, and associated documents for manufacturing processes
  • Assist with raw material supply management activities when applicable
  • Work with Process Development to optimize processes for manufacturing
  • Perform laboratory activities related to clinical manufacturing and maintaining a laboratory notebook

Requirements: 

  • BS in biology, bio/chemical engineering and a minimum of 2-3 years in the biotechnology industry. Experience in manufacturing required and development preferred. Experience in cGMP biologics cell culture manufacturing and cell therapy fields preferred.
  • Computer skills
  • Attention to detail
  • Must have ability to work assigned shift (day, night, holidays and weekends)
  • Must be comfortable with working in a clean room environment, which is an enclosed, restricted space with an assigned pressure and temperature conditions.
  • Must be comfortable with being exposed to human blood components
  • Must be able to work near proximity to strong magnets

 

Preferred Qualifications:

  • Established knowledge of universal precautions for handling human derived materials in BSL-2 containment areas
  • Established knowledge of manufacturing workflows
  • Established knowledge of aseptic techniques and gowning procedures
  • Experience drafting GMP manufacturing batch records would be an asset
  • Experience in process and method validation would be an asset
  • Experience in cell separation techniques and automated equipment
  • Experience in cell washing processes and automated equipment
  • Experience in cryopreservation processes, materials, and equipment