Cell Culture Expert

2 days ago

Brisbane, Queensland, Australia beBeeBioprocessing Full time $190,000 - $220,000
Job Title: Bioprocess Specialist

This is a key member role in the team, where you will work safely and adhere to quality management system requirements.

As a subject matter expert (SME), you will remain trained and qualified in your area of expertise, and display initiative in personal development opportunities to further improve your skills and expertise relevant to the position.

  • Work safely and adhere to quality management system requirements.
  • Act as a SME, remain trained and qualified in your area of expertise, and display initiative in personal development opportunities to further improve your skills and expertise relevant to the position.
  • Provide expert troubleshooting/oversight and support execution of the batch as needed to deliver site key performance indicators of Right First Time and On Time Delivery.
  • Build partnerships and work in collaboration with Operations Managers in mentoring Operations staffs with a focus on building talent depth and demonstrating positive behaviors that align with our values.
  • Support operational production and facility maintenance planning as well as the transfer of new technologies/procedures/equipment to Operations to address production demands as per S&OP and MPS.
  • Review and approve manufacturing batch records, standard operating procedures, logbooks, or validation protocols required for Phase III projects as per ICH guidelines.
  • Collaborate with the Operations team to investigate deviations and determine/implement preventive/corrective actions.
  • Ensure audit readiness within Operations by identifying and addressing gaps as well as preparing story boards and provide expert input during audit.
  • Devise initiatives to drive continuous improvement in Operations.

The ideal candidate will have significant experience and technical expertise in Cell Culture, Harvest Operations, or Downstream Processing.

They will also have excellent written & verbal communication skills, be able to work independently on multiple tasks and balance priorities under pressure, possess strong interpersonal and planning skills with a dedication to excellence, and preferably be educated to minimum degree level in Biology, Chemistry or related field.

Proficiency with Microsoft packages i.e. Word, Excel, PowerPoint, Teams is also required, with experience with SAP being a plus.

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