R&D Analytical Team Lead TLNT1_NI in Newry

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 remediation support for existing finished product methods. The candidate will manage both chemical and physical testing to support both the introduction of new products and where required the lifecycle management of existing products. The candidate will actively assist the regulatory affairs department in responses to regulatory bodies related to analytical methods and results to ensure successful submission of new products. The candidate will liaise with the Quality assurance team regularly, ensuring a high GMP standard of all analytical raw data and documentation within the department.

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 and the laboratory is audit ready at all times.
• To compile and report analytical results taking into consideration internal SOPs, V(ICH) guidelines, Pharmacopeial Monographs and appropriate regulatory guidance's and legislation as applicable.
• Direct Analytical method development, validation and transfer of finished product stability indicating methods.
• Support the analytical testing of pre-approval process validation batches and to engage in any root cause analysis investigations and Risk assessment review.
• Schedule stability study analysis, covering the full V(ICH) study design.
• To troubleshoot projects which necessitate technical analytical input as they arise across the company not limited to R&D projects.
• To schedule team activities within the laboratory to ensure work is carried out in support of projects to agreed timelines.
• To lead trending of analytical data and approve investigations for out of specification results in accordance with company procedures.
• To identify areas for continuous improvement within the team and highlight to department management.
• Oversee training of new and existing laboratory staff, maintenance of associated training records, and identification of training requirements.
• Support preparation and review of Standard Operating Procedures, MOA's, report books and technical documentation.
• To maintain an awareness of current guidelines (USP, Ph Eur, (V)ICH), and industry best practice for stability and process validation studies of pharmaceutical products.
• To oversee and manage the overall performance of the analytical team and direct reports.

Essential Criteria:

• Educated to degree level in a science related discipline.
• At least 4 years previous experience working in a cGMP environment.
• HPLC, UPLC, GC and practical wet chemistry experience.
• Knowledge of VICH guidance for Method Validation of Finished product methods, Process validation and Stability studies.

Desirable Criteria:

• Post graduate qualification.
• Mass spectrometry experience.
• At least 1 year GMP laboratory experience in a supervisory role.
• Previous analytical Method Development and Validation experience.
• Knowledge of AQbD principles.
• Finished product stability study experience.
• Knowledge of Process validation for pre-approval studies.
• Experience with troubleshooting relevant lab equipment; HPLC, UPLC, GC etc.

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