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.
Job Summary
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.
* 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.
Minimum Requirements
* 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 to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
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