About The Position

As part of a start-up, new GMP manufacturing facility focused on tissue engineering and biomanufacturing, as the Biomanufacturing Associate I, Cell Production you will support activities related to the generation and maintenance of all master and working cell banks to meet departmental and company objectives. This role provides valuable hands-on experience in establishing a new GMP manufacturing operation, including the technical transfer of processes from R&D to production readiness.

Requirements

  • Bachelor’s Degree in biology, biotechnology, biomedical engineering, or a related scientific discipline
  • Demonstrated ability to work effectively both independently and as part of a team in a collaborative environment
  • Proficiency with Microsoft Office applications (or equivalent software) and strong general computer skills
  • Strong attention to detail and adherence to Good Documentation Practices (GDP)
  • Excellent verbal and written communication skills
  • Ability to work flexible schedules, including shifts, to support 24/7 operations as needed
  • Proven proficiency in cell culture, and aseptic technique

Nice To Haves

  • 1+ years of cGMP biomanufacturing, cell culture or tissue engineering experience

Responsibilities

  • Operate bioprocess equipment and perform production processes in strict compliance with cGMP, OSHA, and United Therapeutics (Unither) policies and regulations
  • Work as an integral member of the team to support department objectives
  • Routinely perform primary lung cell culture in both 2D and 3D formats under direct supervision to support the generation and maintenance of all master and working cell banks in accordance with established SOPs
  • Routinely perform media formulation in accordance with established SOPs
  • Monitor bioreactor systems parameters (e.g., pressure, flow, timing) and biological indicators (e.g., metabolism, nutrient consumption)
  • Accurately and promptly record data in batch records, logbooks, and system documentation in accordance with Good Documentation Practices (GDP)
  • Perform in-process and end-of-process sampling and testing
  • Conduct routine analyses of in-process measurements and cell culture data
  • Perform basic troubleshooting of equipment issues or process deviations
  • Draft process deviation reports as required
  • Present data and process updates in internal team meetings as needed

Benefits

  • Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.
  • For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
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