Biotechnology Process Lead
1 day ago
Senior Bioprocess Development Position
This is an excellent opportunity to join a dynamic team working on a groundbreaking project that aims to manufacture a life-changing treatment.
The role involves leading key technology transfer activities, developing strategies for process and clean validation, and acting as a Subject Matter Expert in process investigations.
Key Responsibilities:- Liaising with stakeholders to drive technology transfer activities for clinical and commercial new product introduction projects.
- Designing and implementing technology transfer, process and clean validation programs in line with industry and regulatory standards.
- Providing expert guidance on process improvements and optimisation.
- Leading cross-functional teams to deliver business critical projects.
- Maintaining high levels of safety and quality throughout all processes.
- Staying up-to-date with industry trends and developments to inform strategic decisions.
- Substantial experience in biologic drug substance environments.
- Detailed knowledge of biological drug substance upstream and/or downstream purification unit operations.
- Proven track record in technology transfers for clinical or commercial biologics.
- Expertise in automated systems.
- Process validation and cleaning validation experience.
- Minimum of a Bachelor's degree in a technical field (e.g. Engineering, Science) with experience in the biotechnology or pharmaceutical industry.
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