Orla brings more than nine years of specialist recruitment experience and a background of more than 15 years working in healthcare to her role in Wallace Myers International.Contact Orla View all Orla's Jobs
Project Leader Analytical
Our Client a Pharmaceutical Company are currently seeking an experienced Project Leader for their Biologics Division located in Co. Mayo,
Designs and/or executes scientific testing strategies and studies. Leads assay development, assay validation or study conduct, or is involved in preparation of material [e.g. protein, nucleic acid, cells, etc.]. Reviews and interprets study data, communicates results to clients and writes final reports. Serves as Project Scientist, Principal Investigator, Contributing Scientist, Project Leader or Study Director, as applicable. Ensures compliance with protocols and all applicable SOPs. Troubleshoots and resolves assay or technical issues in the laboratory when scientific expertise is needed. May introduce new technologies or introduce improvements in existing technologies. Provides advisory functions to clients designing a program or experiment, dealing with specific dataset interpretation, or when appropriate answering questions from regulatory authorities.
This role shall report to the Head of Analytical Strategy & Scientific Support and the main duties & responsibilities shall be:
* 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 for the projects as required
The Ideal Candidate:
* 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.
For further information or a confidential discuss on the Project leader Analytical
please contact Orla Crowley on 0830286256
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