Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
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 sophisticated analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our team of more than 125,000 colleagues delivers an outstanding 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
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Position Summary:
The Brisbane / Drug Substance Division is one of the five divisions that make up the Pharma Services Group. At this 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.
Key Responsibilities:
- Work safely in accordance with EHS guidelines and implement 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 improve 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 works in collaboration with the Operations Managers in mentoring Operations staffs 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 story boards and provide SME input during audit.
- Devise PPI initiatives to drive continuous improvement in Operations.
Skills and Experience:
- Significant cGMP experience and technical expertise in Cell Culture, Harvest Operations, or Downstream Processing
- Strong interpersonal skills - both written and verbal.
- Ability to work unsupervised and balance priorities
- Strong planning skills and a dedication to excellence
- Preferred to be educated to minimum degree level in Biology, Chemistry or related field
- Knowledge of Microsoft packages i.e. Word, Excel, PowerPoint, Microsoft Teams.
- Use of SFLMS, eDMS, Trackwise, SAP.
Employee Benefits:
- A competitive salary and performance related bonus structure
- Access to Thermo Fisher's global University
- Exposure to market leading & innovative technologies
- Career development opportunities in a leading global organization
We offer competitive compensation and benefits packages, along with opportunities for professional growth and development. Watch as our colleagues explain 5 reasons to work with us.
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.