At a Glance
- Tasks: Lead a team in developing and validating bioanalytical methods in a GLP environment.
- Company: Join a leading veterinary pharmaceutical company focused on innovation and quality.
- Benefits: Competitive salary, career development opportunities, and a dynamic work environment.
- Other info: Opportunity for continuous improvement and involvement in regulatory submissions.
- Why this job: Make a real impact in veterinary science while leading a passionate team.
- Qualifications: Degree in Biochemistry or related field with management experience in a lab setting.
The predicted salary is between 49500 - 60500 £ per year.
We are supporting a GLP-regulated veterinary pharmaceutical company in their search for a Clinical Method Development & Validation Lead to head up their bioanalytical method development and validation team within the GLP Clinical Research section of R&D. This is a hands-on leadership role, combining technical subject-matter expertise with day-to-day management of a laboratory team.
The Role
As Clinical Method Development & Validation Lead, you will act as subject matter expert for the development and validation of accurate, robust bioanalytical methods, providing expert guidance on extraction techniques (including protein precipitation, SPE, and liquid-liquid extraction), chromatographic system optimisation (HPLC, UPLC, LC-MS/MS), and LC column selection. You'll plan, lead, and manage all bioanalytical method development and validation activity in line with GLP, VICH, and internal SOPs, lead troubleshooting and root cause analysis on new and existing methods, and ensure the quality, accuracy, and integrity of all data and documentation produced by the team. You will also manage staff day-to-day, including training, competency assessment, development planning, and mentoring, and support audit readiness, regulatory submissions, and continuous improvement across the department.
About You
- A relevant Biochemistry, Biomedical, or other applicable science-based degree
- At least 4 years' laboratory experience in a GxP environment, including 2 years in a management capacity
- At least 4 years' experience working with HPLC, UPLC, and LC-MS/MS, with frequent use of a chromatography data management system
- Proven ability to develop, optimise, and validate analytical methods
- Proven problem-solving and troubleshooting ability with complex method and equipment issues
- Demonstrated experience with analytical extraction techniques such as protein precipitation, SPE, and liquid-liquid extraction
- Good knowledge of relevant regulatory guidelines
- Excellent oral and written communication and time management skills, with the ability to work under pressure and manage multiple projects and deadlines
- Experience preparing and reviewing validation protocols, SOPs, and SOMs
- Competent in Microsoft Word, Excel, and PowerPoint
Desirable
- Experience with a Design of Experiments (DoE) approach to method development
- Experience using Minitab or an equivalent statistical package
- Working knowledge of GLP laboratory requirements
- Experience with Empower and/or MassLynx chromatography data management systems
- GC experience
- Experience with regulatory inspections and preparing regulatory responses
Clinical Method Development & Validation Lead employer: WALKER COLE INTERNATIONAL LTD
Walker Cole International is an exceptional employer, offering a dynamic work environment where innovation and continuous improvement are at the forefront. As a QA Operations Manager, you will benefit from a culture that prioritises employee development through training and mentorship, while also enjoying the unique advantage of working in a leading manufacturing facility that values operational excellence. With a commitment to performance excellence and collaboration across teams, this role provides meaningful opportunities for professional growth and impactful contributions to the organisation's success.
Contact Details:
WALKER COLE INTERNATIONAL LTD Recruitment Team
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We think this is how you could land Clinical Method Development & Validation Lead
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