Supervisor-Immunology

at  Charles River Laboratories

Req ID #: 224306
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.

JOB SUMMARY

Reporting to the Analytical Technical Operations Manager, this role will be responsible for the Immunoassay area within the Analytical Department. A team of 8-10 Analysts will report to this role.
We are seeking an experienced Immunology Supervisor for our Biologics Division located in Ballina, Co. Mayo, Ireland.

This main duties & responsibilities will be:

• Oversee the quality of work produced by the Immunoassay team and ensure it is conducted in accordance with Standard Operating Procedures and the principles of GMP.
• 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.
• Develop, co-ordinate and implement training for staff on technical aspects of new and existing assays.
• Provide feedback on performance to analysts working on Client specific projects.
• Be involved in preparing costings and proposals based on protocols/project plan of proposed work by clients.
• Assist in the transfer of assays from clients to Analytical Services Department where appropriate.
• Participate in regulatory and client audits and liaising with clients as required.
• Assist in the generation of appropriate SOPs
• Assist Project Leaders in research technical information for incoming new enquiries.
• Compile audit responses in conjunction with the team and the Analytical Technical Operations Manager.
• Support staff with deviations and laboratory investigation reports.
• Raw data review.
• Ensure all raw data and test results are retained and archived according to current SOP’s.
• Assist in Test Item Receipt (LIMS), Storage, Disposal and Decontamination.

JOB QUALIFICATIONS

The following are minimum requirements related to the Immunoassay Supervisor position.

• BSc. 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.
• Proven track record of supervising/managing staff.
• Experience in analytical techniques (e.g. ELISA, Western Blot) essential.
• Ability to problem solve and work on own initiative.

• Oversee the quality of work produced by the Immunoassay team and ensure it is conducted in accordance with Standard Operating Procedures and the principles of GMP.
• 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.
• Develop, co-ordinate and implement training for staff on technical aspects of new and existing assays.
• Provide feedback on performance to analysts working on Client specific projects.
• Be involved in preparing costings and proposals based on protocols/project plan of proposed work by clients.
• Assist in the transfer of assays from clients to Analytical Services Department where appropriate.
• Participate in regulatory and client audits and liaising with clients as required.
• Assist in the generation of appropriate SOPs
• Assist Project Leaders in research technical information for incoming new enquiries.
• Compile audit responses in conjunction with the team and the Analytical Technical Operations Manager.
• Support staff with deviations and laboratory investigation reports.
• Raw data review.
• Ensure all raw data and test results are retained and archived according to current SOP’s.
• Assist in Test Item Receipt (LIMS), Storage, Disposal and Decontamination