Cell Culture Specialist

2 days ago

Brisbane, Queensland, Australia beBeeBioprocessing Full time $105,000 - $165,000
Job Summary

This role is a critical member of our team, responsible for the production of large molecule biologics. The ideal candidate will have significant cGMP experience and technical expertise in Cell Culture, Harvest Operations, or Downstream Processing.

Responsibilities
  1. Ensure compliance with EHS guidelines and adhere to quality management system requirements.
  2. Act as a subject matter expert (SME), remain trained and qualified in area of expertise, and display initiative in personal development opportunities to further improve skills and expertise relevant to the position.
  3. Provide expert troubleshooting/oversight and support execution of the batch as needed to deliver key performance indicators of Right First Time and On Time Delivery.
  4. Mentor operations staff and build partnerships with operations managers to address talent depth and demonstrate positive behaviors that align with company values.
  5. Support operational production planning and facility maintenance as well as the transfer of new technologies/procedures/equipment to operations to address production demands.
  6. Review and approve manufacturing batch records, standard operating procedures, logbooks, or validation protocols required for Phase III projects according to ICH guidelines.
  7. Collaborate with the operations team to investigate deviations and determine/implement preventive/corrective actions.
  8. Ensure audit readiness within operations by identifying and addressing gaps as well as preparing storyboards and providing expert input during audits.
  9. Develop initiatives to drive continuous improvement in operations.
Requirements
  • Significant cGMP experience and technical expertise in Cell Culture, Harvest Operations, or Downstream Processing required.
  • Excellent written & verbal communication skills necessary.
  • Able to work independently on multiple tasks and balance priorities under pressure.
  • Strong interpersonal and planning skills with a commitment to excellence required.
  • Prior education in Biology, Chemistry or related field a plus.
  • Proficiency with Microsoft packages i.e. Word, Excel, PowerPoint, Teams required.
  • Experience with SFLMS, eDMS, Trackwise, or SAP beneficial.

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