Norbrook Laboratories ltd
Clinical Method Development and Validation Lead
Newry
Posted about 18 hours ago
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About Us
In Norbrook we pride ourselves in being one of the top companies in Northern Ireland and one of the top veterinary pharmaceutical companies globally. We develop & manufacture veterinary medicines, supplying products to 120 countries globally. With a strong portfolio of existing products and significant investment in R&D to launch new products annually, we have opportunities for individuals to join us and develop their career in a global company.
Role: Clinical Method Development & Validation Lead
We are currently recruiting for the role of Clinical Method Development & Validation Lead. The successful candidate will lead the team in the development and validation of accurate, precise, robust bioanalytical methods of analysis within the GLP Clinical Research Section of R&D.
Main Responsibilities
- Subject matter expert in method development and validation.
- Provide expert guidance on a wide range of analytical extraction techniques to accurately and reliably extract analytes of interest from various matrices, e.g., protein precipitation, SPE, Liquid-Liquid techniques.
- Provide expert guidance on optimisation of analytical system settings (e.g., HPLC, UPLC, LCMSMS) to deliver reliable chromatographic methods suitable to measure low levels of analytes in a range of matrices.
- Provide expert guidance on LC column selection appropriate to reliably separate various analytes from sample components and matrix.
- Daily supervision, technical, and managerial guidance of the Method Development and validation team.
- Provide expertise and training to deliver methods and validations to facilitate delivery of the New Product Development bioanalytical programme.
- Plan, lead, and manage all bioanalytical method development and validation within the clinical laboratory in line with GLP, protocols, SOPs, VICH, and other relevant international guidance.
- Lead troubleshooting and root cause analysis of new and existing bioanalytical methods.
- Maintain laboratory compliance with GLP, SOPs, company standards, and relevant guidance.
- Assist with management and control of the laboratory consumable spend.
- Maintain audit readiness and an awareness of relevant regulatory guidance/current thinking and act on changes to ensure compliance, quality, and efficiency.
- Ensure the quality, accuracy, and integrity of all data generated within the Method Development and Validation team and oversee the accurate, contemporaneous completion of facility records and documentation.
- Produce robust validated bioanalytical methods and reports and provide to the internal customer within agreed timelines.
- Write and approve Methods of Analysis for routine use within the laboratory.
- Ensure bioanalytical methods are suitably transferred to the analytical group.
- Assessment of method performance after validation to identify and implement continuous improvements within the department.
- Support preparation of documentation and responses to regulatory submissions and queries.
- Conduct thorough investigations on deviations and analytical failures to determine root cause and suitable CAPAs.
- Proactively propose CAPAs, drive completion of actions, and effectiveness checks to monitor and measure impact of change.
- Oversee on-time, in-full responses to QA audit reports.
- Assist in the preparation, implementation, and review of GLP SOPs and ensure adherence to same within the laboratory.
- Ensure adherence to the relevant H&S and GLP Guidelines in the Laboratory at all times.
- Participate in cross-functional H&S meetings; proactively review working practices in the laboratory for adherence to up-to-date H&S requirements and to continually improve on safe working practices for the analytical team.
- Recruit analytical staff and provide training plans, competency assessments, development plans, performance objectives/indicators, and mentoring to facilitate staff development, growth, and retention and to ensure required skills are available to meet the business needs.
- Identify and implement continuous improvements within the department.
- Hold regular team and one-to-one meetings to mentor, lead, and further engage and support staff and build team skills.
- Provide progress updates to management on bioanalytical and method development and validation programs.
- Keep up to date with technology and regulatory expectations in the field of analytical method development and validation.
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Essential Criteria
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- A relevant Biochemistry, Biomedical, or other applicable Science-based degree.
- At least 4 years of lab experience in a GxP laboratory, with 2 years consisting of management.
- A minimum of 4 years’ experience working in a laboratory environment with HPLC, UPLC, LCMSMS, and frequent use of a chromatography data management system.
- Proven ability to successfully develop, optimise, and validate analytical methods.
- Proven ability to problem-solve and troubleshoot complex problems with methods and equipment.
- Highly motivated and able to demonstrate experience and knowledge of a range of analytical extraction techniques, e.g., protein precipitation, SPE, Liquid-Liquid techniques.
- Good knowledge of Regulatory Guidelines.
- Excellent oral and written communication and time management skills.
- Demonstrated ability to work in a high-pressured environment.
- Ability to organise multiple projects and deadlines.
- Experience of preparing and reviewing validation protocols, SOMs & SOPs.
- Competence in Microsoft packages; specifically, Word, Excel, and PowerPoint.
Desirable Criteria
- Experienced in DOE approach to method development.
- Experience in use of Minitab or equivalent.
- Working knowledge of GLP laboratory requirements.
- Empower & Mass Lynx Chromatography Data management system experience.
- GC experience.
- Experience in regulatory inspections and preparing regulatory responses.
- Knowledge of Regulatory Guidelines applicable to the GLP Laboratories.
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Skills
Method Development
Method Validation
HPLC
UPLC
LCMSMS
GLP Compliance
Analytical Extraction
Team Management
Troubleshooting
Root Cause Analysis
CAPA
Regulatory Guidance
VICH Guidance
SOP Writing
Project Management
Data Integrity