Job ref: PDTLFTC25022 Job type: Temporary Location: Newry Closing date: Tuesday 11 Mar 2025 13:00 Job Overview The successful candidate will lead a small team of R&D analysts in developing, optimising, validating, and transferring finished product methods of analysis to routine testing laboratories within Norbrook. This will also include scheduling routine stability testing of R&D batches of finished product with the wider team, all in line with current GMP and V(ICH) requirements. The successful candidate will manage a small team, alongside the wider analytical Pharmaceutical Development group, and oversee the day-to-day running of the laboratory. The role will require the candidate to work on a range of projects including both New Product Development, and commercial support for existing finished product methods. The candidate will be involved in the department scheduling and will have responsibility for the team's daily workload to drive overall project timelines, and report results in a timely and accurate manner to senior management. Main Activities/Tasks Effective management of team, ensuring staff have the skills necessary to operate within their required competency level as per key skills matrix. Manage laboratory activities and personnel to ensure GMP compliance, as well as ensuring the laboratory is in an audit readiness state at all times. Compile and report analytical results taking into consideration internal SOPs, V(ICH) guidelines, Pharmacopeial Monographs, and appropriate regulatory guidance / legislation. Direct Analytical method development, validation and transfer of finished product stability indicating methods. Support the analytical testing of pre-approval process validation batches and engage in any root cause analysis investigations and risk assessment review. Troubleshoot projects which necessitate technical analytical input as they arise across the company (not limited to R&D projects). Schedule team activities within the laboratory to ensure work is carried out in support of projects to agreed timelines. Lead trending of analytical data and approve investigations for out of specification results in accordance with company procedures. Oversee and manage the overall performance of the analytical team and direct reports. Essential Criteria: Educated to degree level (or equivalent) in a science related discipline. Possess a minimum of four years' previous experience working in a cGMP environment. Have HPLC, UPLC, GC and practical wet chemistry experience. Have knowledge of VICH guidance for Method Validation of Finished product methods, Process validation and Stability studies. Duration: Fixed Term, 1 year Location: Newry Additional Information: This role will be based in a site that produces and handles penicillin, and as such, this role would not be suitable for those that have a penicillin allergy. Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered. We regret that applications received after the closing date and time will not be accepted. Norbrook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy, we would particularly like to welcome applicants from the Protestant Community. To Apply Please forward your CV via the APPLY Now button below.