My client, a global CRO company in Co. Mayo, is currently recruiting for a Senior In Vitro (Cell Culture/Virology) Analyst to work in and help to establish a new Cell culture/Virology Laboratory.
This role shall report to the In-Vitro (Cell culture/Virology) Supervisor and the main duties & responsibilities shall be to assist the Department Manager in the following:
- Qualification and/or validation of all equipment for new Cell culture/Virology Laboratory in accordance with GMP and corporate validation requirement standards and guidelines.
- Draw up SOPs and implement testing in strict accordance with SOP(s) ensuring full GMP regulatory compliance as appropriate.
- Generate cell banks and viral stocks for use in specific client testing.
- Establishment of Test Method SOPs and validation of methods, where appropriate.
Core duties shall include: - Complete understanding off all regulatory guidelines.
- Generation of GMP compliant SOPs, Protocols and reports.
- Carrying out test method procedures.
- Liaise with the Quality Department for the generation of all departmental quality documents including audit responses, facility replies and deviation reports.
- Assist in laboratory investigations where necessary.
- Responsible for reporting progress information to Management.
- Provide technical training to team as required.
- Update current standard operating procedures.
- Generate risk assessments for laboratory and test items as required.
The following are minimum requirements related to the Senior In Vitro Analyst position.
- BSc or MSc a relevant science discipline (e.g. Biology, Biochemistry, etc.)
- 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 in-vitro bioassays and project management highly desirable.
- Experience in virology highly desirable.
- In-Vitro Analytical techniques essential.
- Knowledge of biosafety classifications and Code of Practice for the Safety, Health and Welfare at Work (Biological Agents) Regulations 2013 (S.I. No. 572 of 2013) desirable.
- Ability to problem solve and work on own initiative.
For a full Job Spec and to apply for this role please call Zoe on +353 1 2784671 or e-mail zhamilton@thornshaw.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671
