Immunoassay Scientist

at  Charles River Laboratories

Req ID #: 225159
Ballina, Connacht, IE
Full time
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
We are seeking an experienced Immunoassay Scientist for our Biologics Division located in Ballina, Co. Mayo, Ireland.
This role shall report to the Analytical Technical Operations Manager 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.
 Execution of study plans and/or complex methods in the laboratory for transfer/validation/method development and leading troubleshooting efforts as required
 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.

The following are minimum requirements related to the position.

• 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 immunoassay methods e.g. ELISA, Western Blot, etc. essential.
• Ability to project manage multiple studies.
• Knowledge and experience with statistical software.
• Ability to problem solve and work on own initiative.

Please refer the Job description for details