Our growing team of over 1,400 employees work together to deliver world-class scientific products and solutions to a wide range of key markets. With sales, manufacturing and distribution sites scattered across Australia and New Zealand, including Melbourne, Brisbane, Sydney, Auckland, Adelaide, Newcastle and Perth, our scope spans life sciences; specialized diagnostics; food, dairy products and beverages; environmental and industrial; healthcare and analytical instruments including sales, customer service, technical service, supply chain, finance and operations.
At the Brisbane Pharma Services Group (PSG) Biologics site, we are a contract manufacturing organization (CMO) specializing in the production of biopharmaceuticals from mammalian cell cultures. We provide manufacturing services including limited process development and ‘good manufacturing practice’ (cGMP) grade drug substances to customers worldwide. These breakthrough drugs help cure cancer, rheumatoid arthritis, wet age-related macular degeneration, and other chronic and acute diseases.
Job Title: Manager, Process Engineer, Upstream Processing
Reporting to the PE Manager, Manufacturing Science and Technology (MSAT)
Location: Brisbane, Australia
Direct reports: 5 to 10
How you will have an impact:
Patheon’s network of drug manufacturing sites includes St. Louis, USA, Groningen, Netherlands and Brisbane, Australia. The performance of each manufacturing site is closely related to timely introduction of new projects, manufacturing right the first time, and timely delivery of products to customers. As a key member of the Biologics MSAT department, this individual will be responsible for providing technical support to the global Patheon Biologics network.
The Manager, USP Process Engineer will be responsible for leading the USP PE team, driving the alignment of industry best practices, training and mentoring staff, assisting with corporate projects and major deviations / site-related issues. The successful candidate will be a highly motivated individual who can assimilate new information quickly and who enjoys working collaboratively with others in a fast-paced project delivery environment.
What will you do?
- Ensure that the USP PE team meets all key KPIs for the BNE site and the BIO network
- Develop and mentor USP PE team members
- Ensure that new processes and process improvements (including internally developed improvements) are successfully transferred from process development or an external client to operations
- Provide on-site technical support for manufacturing processes across the Patheon network
- Lead troubleshooting efforts and root cause investigations to resolve equipment, process or product related discrepancies
- Communicate the outcome of any investigation to internal and external clients
- Provide direction to development sites regarding the adjustment of new process installations
- To support late-stage process validation programs
- Identify improvements and share manufacturing best practices across the network
- Transfer of technology, development of facilities and implementation of new production processes
- Generate, review and approve GMP documentation including Standard Operating Procedures (SOPs), Technical Handover Documents, Master Batch Records, Process Flow Charts, Risk Assessments and Bills of Materials
- Implement new technologies and equipment within the production plant
How will you get here?
- Graduate degree in science or engineering (biology, biotechnology, biochemistry, chemistry)
- Previous experience managing teams is preferred
- 5+ years of experience in a GMP biopharmaceutical manufacturing environment or process development lab/pilot plant
- Knowledge of process development, scale-up and cGMP manufacturing of protein-based pharmaceuticals
- Experience with single-use equipment and the use of automated process equipment in a GMP environment
- Experience with scaling up purification unit operations, including chromatography and all types of filtration
- Trained in conducting Tap Root surveys
- Strong analytical and problem solving skills coupled with the ability to work both independently and as part of a team
- Ability to work within a matrix management system and to influence and negotiate collaboratively with others without direct authority
- Experienced in participating and leading PPI Kaizen projects
- Autonomous and results-oriented
- Knowledge of FDA/EMA regulatory requirements applicable to biologics. Ability to apply GMP regulations and other international guidelines to all aspects of the job
- Strong interpersonal and communication skills; written and oral, and a demonstrated ability to make key decisions
- Technical knowledge of biopharmaceutical manufacturing, validation, raw materials, analytical testing and materials management is desirable
- Proficiency in computers (MS Office) and the Internet. Working knowledge of controlled documentation and data systems.
What’s in it for you?
- Competitive compensation and performance-related bonus structure
- Access to Thermo Fisher Global University
- Development opportunities as part of a rapidly growing global organization
Thermo Fisher Scientific Inc. (NYSE: TMO) is the global leader in serving science, with revenues of more than $24 billion and approximately 110,000 employees worldwide. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our clients accelerate life science research, solve complex analytical challenges, improve patient diagnostics, bring medicines to market and increase laboratory productivity. Through our leading brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unparalleled combination of innovative technologies, shopping convenience and comprehensive services.