Project Leader - Raw Materials

I am currently recruiting for an experienced Project Leader for my client’s Biologics Division located in Co. Mayo, Ireland. This role would be working on Raw Materials projects and is a full time permanent position.

This role shall report to the Head of Operations Analytical and Biosafety and the main duties & responsibilities shall be:

• Project Management of development and/or verification/validation of analytical methods that use equipment like HPLC, Ion and Gas Chromatography, spectrophotometers as well as wet chemistry techniques and compendial methods in the Analytical Services Department.   The role will involve management of subcontractors, ensuring samples are tested and results are released within the required timelines i.e. ensuring tests are scheduled and data is reviewed in a timely manner. 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. 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. 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.

The following are minimum requirements related to the Project Leader position. 

•    PhD in a relevant science discipline (e.g. Chemistry, Biochemistry or Biotechnology)
•    A minimum of 3 years relevant experience 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.
 

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