Naynesh Mistry at CK Science is currently recruiting for an Analytical Team Leader to join a leading pharmaceutical company based in Northern Ireland on a permanent basis.
As an Analytical Team Leader you will provide technical leadership, management and coaching for operational analytical teams and enable the delivery of complex projects. The post holder will manage the progress of Analytical work to GMP requirements and ensure that project schedules are met and that the work is carried out efficiently and accurately, providing regular updates to their Departmental Manager.
- 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 (e.g. the strategy to develop, verify/validate or transfer analytical methods, stability study design etc). Support Technical leaders, and Senior Analysts with strategy setting and approve the approaches they propose (as appropriate).
- Actively manage the performance of Technical Leaders, Senior Analysts, Analysts and Technicians assigned as their direct and indirect reports.
- Take the lead in technical assessment for quotations, and support Business Development activities / visits (internal/external).
- Provide support and front (as required) Client / Regulatory cGMP audits. And complete all assigned actions from audits promptly.
- 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 departments needs.
- Overall responsibility for team adherence to Quality Management System document closure timelines (e.g. CAPA, CRF etc etc).
The successful Analytical Team Leader will have the following qualifications, skills and experiences:
- A degree in Chemistry or a Life Science subject with a significant chemistry component.
- Significant experience of analysing and leading analytical development activities for solid oral dose 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
- Significant experience of supervising and managing cGMP laboratory activities and staff.
- A thorough understanding of the pharmaceutical drug development process, and experience preparing regulatory CMC dossier sections.
- Previous experience of using statistical data analysis techniques.
- Experience in cGMP audits and knowledge of Microsoft Office (Word, Office, Excel etc)
If successful you will be joining one of the leading API manufacturer in Northern Ireland. Other benefits include:
- An attractive remuneration package will reflect the importance of this role
- 6.8 weeks annual leave
- Company pension scheme
- Enhanced sick pay and maternity entitlements,
- Healthcare plan and opportunities for learning and development
- Access to a company restaurant and parking facilities.
How to apply:
To apply for this Analytical Team Leader position contact Naynesh Mistry via email firstname.lastname@example.org or telephone: 0114 283 9956. Please quote reference SH25404 in all correspondence.