Do you have HPLC Method Development and Validation experience? Do you have line management experience?
This is an exciting opportunity to join an international organisation as an Analytical Team Leader. This established CDMO has been serving the pharmaceutical and biotech sectors globally for over 50 years. They have grown organically over the past five decades, now employing more than 6,600 highly skilled personnel across Europe, USA, and Asia.
As an Analytical Team Leader, you will provide technical leadership, management and coaching for operational analytical teams, and enable the delivery of complex projects.
This is a permanent position, and it is based in Loughborough.
Rewards
- Competitive salary
- Attractive annual bonus
- Pension plan
- Healthcare
- Flexible hybrid working model (work from home one day week)
- 34 days paid annual leave (including Bank holidays)
Role Responsibilities
- Provide technical and operational leadership, training and coaching to Technical Leaders, Senior Analysts, Analysts and Technicians.
- Take full ownership for: the analytical activities required as part of their assigned projects, identifying technical problems/issues, developing solutions, and fully implementing these solutions with agreement from their departmental manager where appropriate.
- Define the analytical strategy for new and ongoing projects
- Provide support and front (as required) Client/Regulatory cGMP And complete all assigned actions from audits promptly.
- Ensure all project work is effectively and efficiently delivered on time to the specified/expected quality and ensure budgeted contract hours are adhered to.
- Prepare, review and approve any protocols, reports and other associated project / GMP documentation (e.g. data packs, Methods, specs) that are required to fulfil the projects or department’s needs.
- Overall responsibility for team adherence to Quality Management System document closure timelines (e.g. CAPA, CRF etc).
Essential Requirements
- BSc (or equivalent) in Chemistry or a Life Science subject with a significant chemistry component
- Significant experience of analysing and leading analytical development activities for pharmaceutical drug products in a GMP environment.
- Significant experience of stability study design and testing, HPLC method Development, HPLC Method Validation, Dissolution Method Development, Dissolution Method Validation.
- Modern Chromatography Software knowledge.
- Significant experience of supervising and cGMP laboratory activities and staff.
- A thorough understanding of the pharmaceutical drug development process, and experience preparing regulatory CMC dossier sections.
- Experience of using statistical data analysis techniques and designing statistically relevant experiments.
- Proven ability to successfully lead business improvement projects using recognised process improvement techniques.