JOB DESCRIPTION

As a key member of the Patheon / Thermo Fisher Scientific team, discover meaningful work that makes a positive impact on a global scale! Join us in bringing our mission to life every day.

ABOUT US

Brisbane / Drug Substance Division is one of the five divisions that make up the Pharma Services Group. At the Brisbane site we specialize in GMP clinical and commercial manufacturing of large molecule biologics including for clinical Phase I, II, and III, applying powerful single use bioreactors and biologics technologies. This allows us to serve the needs of small/emerging, mid-sized, and large pharma sectors globally. The network of Patheon’s drug substance manufacturing sites include St. Louis, USA, Groningen, Netherlands and Brisbane, Australia.
Job Title: Bioprocess Specialist
Reports to: Operations Technical Support Manager
Position Location: Brisbane, Australia

QUALIFICATIONS AND EXPERIENCE

• Must have significant cGMP experience and technical expertise in Cell Culture, Harvest Operations, or Downstream Processing.
• Have excellent written & verbal communication skills.
• Able to work independently on multiple tasks and balance priorities under pressure.
• Possess strong interpersonal and planning skills with a dedication to excellence.
• Preferred to be educated to minimum degree level in Biology, Chemistry or related field.
• Proficiency with Microsoft packages i.e. Word, Excel, PowerPoint, Teams.
• Experience with SFLMS, eDMS, Trackwise, or SAP is a plus.

• Work safely in accordance with EHS guidelines and adhere to Patheon cGMP Quality Management System requirements.
• 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.
• Provide expert troubleshooting/oversight and support execution of the batch as needed to deliver the site key performance indicators of Right First Time and On Time Delivery.
• Build partnerships and work in collaboration with the Operations Managers in mentoring Operations staffs with a focus on building talent depth and demonstrating positive behaviors that align with our 4i 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 PPI initiatives to drive continuous improvement in Operations.