Scientist III, Formulation Specialist
4 weeks ago
We are seeking a highly skilled Scientist III, Formulation to join our Brisbane / Drug Substance Division. As a key member of our team, you will be responsible for ensuring the safe and efficient production of large molecule biologics.
Key Responsibilities- Work safely in accordance with EHS guidelines and implement to Patheon cGMP Quality Management System requirements.
- Develop and maintain subject matter expertise in area of expertise, and display 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 work 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.
- 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.
- 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 are an EEO/Affirmative Action Employer and do 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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Brisbane, Queensland, Australia Thermo Fisher Scientific Full timeAbout the Role:We are seeking a highly skilled Scientist III, Formulation to join our Brisbane / Drug Substance Division. As a key member of our team, you will be responsible for working safely in accordance with EHS guidelines and implementing Patheon cGMP Quality Management System requirements.Key Responsibilities:Develop and maintain subject matter...
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