The Job

It is the post holder's objective to provide technical leadership and coaching for Senior Analysts, Analysts and Technicians and enable the delivery of complex projects.

The post holder will act as the primary analytical lead for their assigned project. They will execute, delegate and monitor the progress of work on a daily basis to ensure project timelines are met and to communicate progress to internal and external clients.

Responsibilities

• To provide technical and operational leadership, training and coaching to Senior Analysts, Analysts and Technicians.
• To 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 line manager/departmental manager where appropriate.
• To 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 Senior Analysts with strategy setting and approve the approaches they propose.
• To actively manage the performance of Senior Analysts, Analysts and Technicians assigned as their direct and indirect reports.
• To assist their Team Leader / Group Leader with technical assessments for quotations, and support any Business Development activities that are required of them.
• To provide support as required during Client / Regulatory cGMP audits and complete all assigned actions from audits promptly.
• Manage internal team resources/schedules ensuring adequate planning and resource allocation for assigned development projects. Report issues and propose solutions to their Team Leader / Group Leader on an ongoing basis.
• To ensure all project work is effectively and efficiently delivered on time to the specified/expected quality and ensure budgeted contract hours are adhered to.
• To highlight project scope changes and communicate these changes to the Project Manager in a timely fashion to allow contract negotiation/re-costing as appropriate.
• To ensure laboratory cGMP procedures / systems are adhered to and investigate / manage any non-compliance issues (where appropriate involving their Team or Group Leader).
• 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 departments needs.
• To take full responsibility for SAR investigations and ensure all investigations are conducted in a thorough and timely manner in accordance with procedures. Support Senior Analysts in setting investigation strategies and approve the designs for investigations.
• To act as the primary analytical team member on PDS projects. To execute, delegate and monitor the progress of work on a daily basis with regard to the project plan, and communicate progress to internal and external stakeholders.

Skills

• B.Sc. (or equivalent) in Chemistry or a Life Science subject with a significant chemistry component.
• Significant experience of analysing Pharmaceutical drug products in a GMP environment.
• Significant experience in:
• * Stability study design and testing
• * HPLC method Validation
• * HPLC method Development
• * HPLC analysis
• Experience of supervising and managing cGMP laboratory activities and staff meeting demanding timelines.
• Experience of leading analytical development activities in support of Pharmaceutical development projects.
• Understanding of the pharmaceutical drug development process.
• Experience of client interaction in a contract manufacturing company

Matchtech acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers and is part of Gattaca Plc.

Gattaca Plc provides support services to Matchtech and may assist with processing your application.