1. Oversee the quality of work produced by the Cell Culture/Virology team and ensure it is conducted in accordance with Standard Operating Procedures and the principles of GMP.
2. To implement and supervise safe working methods within the team and to inform and instruct staff of these. Comply with all Health and Safety regulations and procedures.
3. Develop, co-ordinate and implement training for staff on technical aspects of new and existing assays.
4. Responsible for providing feedback on performance to analysts working on Client specific projects.
5. Be involved in preparing costings and proposals based on protocols/project plan of proposed work by clients.
6. Assist in the transfer of assays from clients to the Department, where appropriate.
7. Participate in regulatory and client audits and liaising with clients as required.
8. Assist in the generation of appropriate SOPs.
9. Assist Project Leaders in research of technical information for incoming new enquiries.
10. Responsible for compiling audit responses in conjunction with the team and the Analytical Functional Manager.
11. Responsible for supporting staff with deviations and laboratory investigation reports.
12. Raw data review.
13. Responsible for ensuring all raw data and test results including protocols, reports etc are retained and archived according to Laboratories SOP’s.
14. Responsible for preparing ‘Presentations’ and the delivery of same to the Cell Culture/Virology team, other departments and to Clients as required.
15. Assist in Test Item Receipt (LIMS), Storage, Disposal and Decontamination.
16. Liaise with consultants and external services (e.g. subcontract laboratories) as appropriate.
17. Liaise with other departments to ensure that the laboratory areas and all equipment maintained in appropriate working conditions.
18. Responsible for purchasing new equipment and spare/replacement parts as required.
19. Responsible for maintaining stock of supplies (chemicals, consumables) needed for routine activities within the team.
20. Scheduling daily tasks to analyst, ensuring appropriate workload is not exceeded.

• BSc. In a relevant science discipline (e.g. Biology, Biochemistry or Biotechnology)
• A minimum of 3 years relevant experience in Scientific Research within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.
• Proven track record of supervising/managing staff.
• Experience in analytical techniques (e.g. HPLC, ELISA, Western Blot) essential.
• Ability to problem solve and work on own initiative.
• ·      Excellent communication and organizational skills.

Role Description