Job Description

As part of the Patheon / Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.

About us

Brisbane / Drug Substance Division - 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 includes St. Louis, USA, Groningen, Netherlands and Brisbane, Australia.

Discover Impactful Work!

• Take your career to the next level with a Process Engineering role in the growing and rapidly developing pharmaceutical biologics industry!
• The Support Engineer – Process Engineering (USP) is part of the successful Manufacturing Sciences (MSAT) team which is highly regarded within and outside Patheon Biologics.
• As a member of the USP PE team, you will have the opportunity to learn our successful new product introduction (NPI) and technology transfer processes supported by our global partners and standards.
• Become acquainted with working in a highly regulated cGMP environment and learn from our industry leading and renowned Process Engineers.
• You will support Process Engineers throughout the tech transfer and upstream processing steps.
• The opportunity to expand your knowledge of mammalian cell culture including fed batch and perfusion culture.

A day in the Life:

• Support mammalian cell culture processes for the production and manufacturing of recombinant proteins (including mAbs).
• Support Process Engineers with technical transfer assessment of facility fit, bioreactor processes, media, cell culture scale-up, and clarification (harvest) with support from the wider Manufacturing Sciences (MSAT) team.
• Prepare protocols, reports, process flow diagrams, and manufacturing batch records, including the evaluation and interpretation of technical batch data.
• Demonstrate a strong focus on continuous improvement. Help identify workflow, resource, or process gaps and complete improvement projects.

Education

• Tertiary degree in Science or Engineering (biology, biotechnology, biochemistry, chemistry)

Experience

• Experience working in a manufacturing or process development role is preferred.
• Knowledge of process development, scale-up and cGMP manufacturing using cell culture systems is preferred.
• Experience working in a highly regulated environment. Knowledge of FDA/EMA regulatory requirements applicable to biologics is preferred.
• Ability to apply GMP regulations and other international guidelines to all aspects of the position
• Strong MS Excel, PowerPoint and Word skills.
• Excellent problem solving and critical thinking skills, including strong attention to detail.
• Excellent writing, communication and presentation skills.
• Ability to analyze and summarize complex scientific data.
• Excellent organization, planning, and time management skills.
• Self-motivated, willing to learn, independent and a proactive driving force of efficient execution.
• Ability to work constructively on a team and adaptable to function in a changing environment

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Other Job Requirements:

• Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment
• Your position may require you to participate in on call work. If you are on call you are required to be available for immediate return to work outside of your normal and regular work pattern. Should this be a requirement of your position, you will be remunerated per the Company’s policy.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status