R&D Analytical Team Lead

• 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

• 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.