Job Summary
Reporting to the Analytical Laboratory Manager, this role will be responsible for the Analytical testing within the Analytical Department. A team of Analysts will report to this role.
We are seeking an experienced Analytical Supervisor for our Biologics Division located in Co. Mayo, Ireland.
This main duties & responsibilities shall be:
Responsibilities
* Oversee the quality of work produced by the Analytical team and ensure it is conducted in accordance with Standard Operating Procedures and the principles of GMP.
* 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.
* Develop, co-ordinate and implement training for staff on technical aspects of new and existing assays.
* Responsible for providing 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.
* Responsible for compiling audit responses in conjunction with the team and the Analytical Technical Operations Manager.
* Responsible for supporting staff with deviations and laboratory investigation reports.
* Raw data review.
* Responsible for ensuring all raw data and test results including protocols, reports etc are retained and archived according to Charles River Laboratories SOP’s.
* Responsible for preparing ‘Presentations’ and the delivery of same to the Analytical Services Department team and to Clients as required.
* Assist in Test Item Receipt (LIMS), Storage, Disposal and Decontamination.
* Liaise with consultants and external services (e.g. subcontract laboratories) as appropriate.
* Liaise with other departments to ensure that the laboratory areas and all equipment maintained in appropriate working conditions.
* Responsible for purchasing new equipment and spare/replacement parts as required.
* Responsible for maintaining stock of supplies (chemicals, consumables) needed for routine activities within the team.
* Scheduling daily tasks to analyst, ensuring appropriate workload is not exceeded.
Minimum Requirements
* 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. HPLC, compendials, CE-SDS, icIEF, GC) essential.
* Ability to problem solve and work on own initiative.
* Excellent communication and organizational skills.
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