The role will assist with driving CMC Scale-Up activities and experimental activities enabling the advancement of the Company’s pipeline, process or technology capabilities. To contribute to process development and validation activities, ensuring regulatory compliance.
- You will conduct and design experiments to support manufacturing at GMP and regulatory submissions
- Enable transfer, communication and technical support of manufacturing processes to contract manufacturing organisation
- Review technical documentation and advise advancement of process validation studies, to ensure success and regulatory compliance, leading to BLA/MAA
- Contribute to CMC components of regulatory submissions
- Supporting and Offering insights on technical and investigational aspects as well as the relevance to the wider objectives of the project, department and company
- Keep abreast of advances in the CMC regulatory and upstream and /or downstream processing field
- There is also the opportunity to manage a small team.
You will need experience of process validation for biopharmaceuticals, familiar with the principles of GMP.
Project managed simultaneous projects within bioprocess development, understanding the impact across the wider project team.
Demonstrate an advanced level of upstream and/or downstream process development.
Designed successful scaled- up processes for drug manufacturing for clinical use.
Researched and resolved complex situations and issues through further external research using own initiative.
Ideally have experience of line managing a small team, and management of a group budget.
You will need a BSc or MSc or equivalent in protein engineering, microbiology, biochemistry, molecular biology or related discipline. A PhD is desirable in related discipline.