This role will lead a group conducting experimental investigations enabling the advancement of the Company’s pipeline, process, or technology capabilities. To contribute to process development and validation activities, ensuring regulatory compliance.
- Managing a small group to achieve the delivery of projects to the agreed timescales and standards, identifying issues that need to be addressed and escalating these as needed.
- Supporting and offering insights on technical and investigational aspects as well as the relevance to the wider objectives of the project, department and company.
- Contribute to CMC components of regulatory submissions.
- Conduct and design experiments to support manufacturing at GMP and 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/upstream development/microbial fermentation field.
- Laboratory records & equipment: Ensuring that all records for the group, data and information are up to date, on time and recorded to the correct standard and that equipment is being used correctly and effectively.
- Responsible for the day-to-day compliance with all H&S within the Group
You will need experience of project management of simultaneous projects within upstream process development, understanding the impact across the wider project team.
Experience of managing, mentoring and/or coached individuals to greater success and advised on areas for improvement.
Owned and delivered significant changes that have measurably improved company pipeline, process or technology capabilities and leading teams through adoption, implementation and change.
Demonstrate an advanced level of upstream process development and microbial fermentation skills.
Proven ability to analyse, interpret complex datasets, and propose sound experimental strategies.
Researched and resolved complex situations and issues through further external research using own initiative.
Ideally you will have experience of managing a small team and group budget, and familiar with regulatory CMC document writing contributions (IND,IMPD). Process validation experience and support of BLA/MAA submissions for a biopharmaceutical.
You will need a BSc. or MSc. or equivalent in protein engineering, microbiology, biochemistry, molecular biology or related discipline. Desirable would be a PhD in a related discipline.