Analytical Project Leader

Project Leader – Analytical

On behalf of my client, I am recruiting for a Project Leader – Analytical.

I am recruiting for an experienced Project Leader for my client’s Biologics Division located in Co. Mayo, Ireland. The successful candidate will report to the Head of Analytical Strategy and Scientific Support.

 Key Responsibilities:

• Research and develop new analytical methodologies to meet client requirements and/or company strategic objectives.
• Ensure all new methods are validated in accordance with ICH guidelines, where appropriate.
• Draw up study plans and execute studies in strict accordance with study plan and SOPs ensuring full GMP regulatory compliance, where appropriate.
• Liaise with the Quality Department for the generation of audit responses, deviation reports and for the compilation of study reports.
• Responsible for leading laboratory investigations, where necessary.
• Responsible for reporting project progress information to Management.
• Provide technical training to scientific team, as required.
• Day to day liaison with clients regarding current and new projects.
• Involvement with regulatory and client audits.
• Ensure all new equipment is qualified and validated in accordance with GMP and corporate validation requirement standards and guidelines.
• Generate new and update current standard operating procedures.
• Generate risk assessments for various projects as required.

Qualifications/Experience:

• PhD in a relevant science discipline (e.g. Chemistry, Biochemistry or Biotechnology)
• A minimum of 3 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.
• Experience in study design, assay development, optimization, ICH analytical validation and project management.
• Experience in analytical techniques (e.g. HPLC (ELS, CAD, etc.), UPLC, GC, flame photometry, etc.) essential.
• Ability to project manage multiple studies.
• Knowledge and experience with statistical software.
• Ability to problem solve and work on own initiative.

If you are interested in applying for this role, please call Zoe on +353 1 2784671 or email zhamilton@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com