Work Schedule
Other

Environmental Conditions
Office

Job Description

Join Thermo Fisher Scientific and make a difference on a global scale. Help our customers improve the world by developing solutions for challenges like protecting the environment and finding cures for cancer. Contribute to meaningful work that impacts lives every day.

Location/Division Specific Information

The Brisbane, Drug Substance Division is one of five divisions that make up the Pharma Services Group (PSG). 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.

• Work safely in accordance with EHS guidelines and adhere to Patheon cGMP Quality Management System requirements.
• Become a subject matter expert, remains trained and qualified in area of expertise, and displays initiative in personal development opportunities to further enhance skills and expertise relevant to the position.
• Provide SME 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.
• Establish and maintain the training programs in Operations.
• Build partnerships and work collaboratively to develop trainee-focused content to improve operational success and sustainability.
• Implement training as needed for both new hires and established employees.
• Displays positive behaviors using the 4i values and instills this behavior throughout the training & development of the Operations staffs.
• Track and trend the qualified status of Operations staffs to maintain training compliance.
• Write and update standard operating procedures and work instructions for processes using the Electronic Document Management System.
• Assists Operations group with deviation investigation and determination/implementation of preventative/corrective actions.
• Devises PPI initiatives to drive continuous improvement in Operations.

• Preference for a Degree level in Biology, Chemistry or related field or related work experience.

• Must have significant cGMP experience and technical knowledge in Cell Culture and Harvest Operations.
• Experience using SFLMS, eDMS, Trackwise, SAP.

• Excellent written & verbal communication skills.
• Ability to work under pressure on multiple tasks and manage conflicting priorities independently.
• Possess strong interpersonal skills and a dedication to excellence.
• Sufficient knowledge of Microsoft packages i.e. Word, Excel, PowerPoint, Microsoft Teams.

• Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
• Flexibility: Balance your work and personal life with flexible arrangements.
• Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
• Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you.
• Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.