Join to apply for the Principal Scientist role at Ipsen.
We are excited to announce a new Principal Scientist position within our Biologics development team. This is a permanent position preferably based at our Wrexham site, with potential for hybrid working at our Paddington or Dublin offices.
As the successful candidate, you’ll lead all aspects of Drug Substance development, tech transfer, validation, and regulatory submission for Biologics drug substance. You’ll provide strategic and technical input into drug substance development and manufacturing technologies, leading cross-functional teams responsible for CMC development programs and process improvements. This role also involves incorporating sustainability-by-design principles to future-proof Ipsen processes.
This is a fantastic opportunity for a seasoned professional to make a significant impact in a dynamic environment.
Role Responsibilities
1. Lead, design, and execute research activities within GxP and other applicable requirements.
2. Demonstrate advanced knowledge of industry trends and standards.
3. Plan and oversee experiments, analyze data, and write reports. Apply advanced process control testing strategies using QbD/DoE approaches.
4. Manage process transfer, validation, and lifecycle activities.
5. Contribute to regulatory documentation and ensure compliance with GxP/EHS standards.
6. Support cross-site interactions and external collaborations.
7. Lead troubleshooting and provide technical guidance.
8. Train and mentor teams on new processes and technologies.
Sustainability and Process Optimization
* Design and optimize biologics manufacturing processes to reduce environmental impact, including waste and energy use.
* Develop tools for evaluating sustainability impacts of development decisions.
* Identify opportunities for process intensification and circularity.
Knowledge & Experience (Essential)
* Degree or equivalent in relevant field.
* Extensive experience in mammalian biologics development.
* Experience in regulatory documentation.
* Broad understanding of all aspects of CMC development throughout the product lifecycle.
Knowledge & Experience (Preferred)
* PhD or equivalent qualification.
* Operational Excellence certification.
* Knowledge of Life Cycle Assessments and applying Operational Excellence (Yellow/Green belt).
Join our award-winning team at Ipsen Wrexham, committed to innovation and excellence in biologics development. With significant recent investments and site expansions, this is an exciting time to be part of Ipsen.
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