Job Description
About us
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world Healthier, cleaner and Safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 125,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com .
Position Summary:
The 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 includes St. Louis, USA, Groningen, Netherlands, and Brisbane, Australia.
The Upstream/Downstream Bioprocess Specialist reports to the Operations Technical Support Manager of the Pharma Service Group (PSG) and the role is based in Brisbane.
Key Responsibilities:
Works safely in accordance with EHS guidelines and adheres to Patheon cGMP Quality Management System requirements.
Becomes subject matter expert (SME), 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.
Build partnerships and work collaboratively with the Operations Managers in mentoring Operations staff with a focus on building talent depth and demonstrating positive behaviors as per 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 manufacturing batch records, standard operating procedures, logbooks, or validation protocols required for Phase III projects as per ICH guidelines.
Assist Operations group with deviation investigation and determination/implementation of preventative/corrective actions.
Ensure audit readiness within Operations by identifying and addressing gaps as well as preparing storyboards and providing SME input during audits.
Devise PPI initiatives to drive continuous improvement in Operations.
Skills and Experience:
Must have at least 2+ years' cGMP experience and technical expertise in Cell Culture, Harvest Operations, or Downstream Processing.
Excellent written & verbal communication skills.
Ability to work unsupervised, under pressure on multiple tasks and manage priorities independently.
Strong organizational and planning skills and a commitment to excellence.
Preferred to be educated to minimum Degree level in Biology, Chemistry or related field.
Sufficient knowledge of Microsoft packages i.e. Word, Excel, PowerPoint, Microsoft Teams.
Use of SFLMS, eDMS, Trackwise, SAP.
We offer competitive compensation and benefits packages, along with opportunities for professional growth and development. If you are a motivated individual with a passion for demand planning and inventory management, we invite you to apply for this exciting opportunity.
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.
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