On behalf of my client, I am recruiting for a Senior Molecular Biology Analyst to work in and help establish new PCR Laboratories.
This role shall report to the Molecular Biology Supervisor and the main duties & responsibilities shall be to assist the Supervisor and Department Manager.
Key Responsibilities:
- Qualification/validation of all equipment for new PCR Laboratories 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.
- Interpret data and troubleshoot assays.
- Participate in the validation and qualification of molecular assays.
- Complete understanding off all regulatory guidelines.
- Generation of GMP compliant SOPs, Protocols and reports, and update SOPs where required
- Perform laboratory activities necessary for molecular biology testing including but not limited to reagent preparation, laboratory maintenance, generation of routine GMP reports and routine testing of client samples.
- 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.
- Generate risk assessments for laboratory and test items as required.
- BSc or MSc a relevant science discipline (e.g. Molecular Biology)
- 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 molecular biology techniques, especially PCR and Q-PCR and project management essential.
- Experience in establishment and validation of molecular biology methods is highly desirable.
- 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 Ciara on +353 1 2784671 or e-mail cphillips@thornshaw.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: +353 1 2784671
