WALKER COLE INTERNATIONAL LTD

We're working with a growing biopharma environment looking for a senior-level analytical leader to take ownership of analytical activities supporting biologic products as they move from development into routine manufacture. This is a hands-on technical role with real influence - shaping analytical approaches, supporting technology transfer, and ensuring methods remain robust, compliant, and fit for purpose across the product lifecycle. What you'll be doing: Setting and driving analytical approaches for biologic programmes, from development through to commercial supply Leading method development, validation, optimisation, and ongoing lifecycle improvements Supporting tech transfer and scale-up activities, working closely with manufacturing and MSAT teams Overseeing analytical data review, interpretation, and technical reporting Acting as a key analytical voice for regulatory activities, audits, and submissions Introducing new techniques, methods, and equipment to strengthen analytical capability Providing technical guidance and mentoring to more junior scientists within the team What they're looking for: Strong background in pharmaceutical analytical development within a CMC setting Solid experience working with biologics, including characterisation and method lifecycle management Proven ability to lead technical workstreams and influence cross-functional teams Comfortable working across quality, manufacturing, regulatory, and external partners Clear communicator who can balance technical depth with practical decision-making This would suit someone who enjoys being technically close to the work, while also shaping strategy and standards across analytical activities.

Walker Cole International is searching for a Quality Manager / Responsible Person (RP) to join a Pharmaceutical company with distribution operations in the Midlands. This role combines strategic Quality Management with hands-on GDP responsibilities, acting as the named RP while leading site-wide quality activities. You will be responsible for: Acting as the named Responsible Person, ensuring compliance with UK and EU GDP regulations and certifying product release for distribution. Managing and continuously improving the Quality Management System (QMS), including deviations, CAPAs, change control and risk management. Leading and supporting internal and external audits and inspections, including MHRA and third-party audits. Driving a strong Quality and GDP culture across the business through leadership, coaching and continuous improvement initiatives. The successful candidate will have: A degree or equivalent qualification in a scientific or related discipline. Eligibility to act as a Responsible Person under UK and EU GDP requirements. Proven experience in a GDP-regulated pharmaceutical environment, with responsibility for quality systems and compliance. Strong working knowledge of GDP, MHRA and EU guidelines, with the ability to influence stakeholders at all levels. Quality Manager Responsible Person RP Quality Assurance QA Pharmaceutical GDP Good Distribution Practice MHRA EU GDP Quality CAPA eQMS PQS Pharmaceutical Quality System Distribution Supply Chain Regulatory QMS Quality Management System

Walker Cole International is searching for a Senior R&D Scientist - E&L and Nitrosamine Method Development - to join a global pharmaceutical company at their R&D and GMP-regulated site in the UK. As the Senior Scientist, you will play a key role in developing and validating analytical methods to support Extractables, Leachables, and Nitrosamine testing across pharmaceutical products and materials. Your responsibilities will include: Leading and supporting risk assessments and analytical method development for E&L and Nitrosamines. Developing, validating, and transferring LC-MS and GC-MS methods in compliance with GMP and regulatory guidelines. Performing data interpretation, troubleshooting, and technical investigations to resolve analytical issues. Preparing technical reports and regulatory documentation to support product filings and submissions. Collaborating with QC, QA, and Regulatory Affairs teams to ensure analytical compliance and product quality. Contributing to continuous improvement within analytical R&D and supporting method optimisation projects. To be successful, you will have: Proven experience in Extractables & Leachables and/or Nitrosamine analysis within a GMP-regulated laboratory. Hands-on experience with LC-MS or GC-MS and method validation techniques. Strong problem-solving, communication, and documentation skills. Analytical Chemistry Extractables & Leachables Nitrosamines LC-MS GC-MS Method Development Validation GMP Pharmaceuticals R&D

Walker Cole International is searching for a Process Technician to join a global pharmaceutical manufacturing business at their high-volume, GMP-regulated production site in Cambridgeshire. As the Process Technician, your responsibilities will include: Operating and monitoring pharmaceutical manufacturing equipment in compliance with GMP, safety, and environmental regulations. Carrying out raw material charging, basic equipment maintenance, and cleaning procedures to support batch production. Maintaining accurate production records and reporting any deviations or quality issues. Supporting investigations, process improvements, and updates to Standard Operating Procedures (SOPs). Collaborating with cross-functional teams and adapting to changing operational needs across multiple production areas. To be successful as the Process Technician, you will have: Experience in a GMP-regulated or manufacturing environment (pharmaceuticals or chemical manufacturing preferred). Strong attention to detail, communication, and observational skills. A proactive, team-oriented approach with the flexibility to work across different production zones. Willingness to learn and contribute to continuous improvement initiatives. A strong standard of written English and basic numeracy for documentation and reporting. Manufacturing Technician Process Operator GMP Pharmaceutical Production Cleanroom Regulated Manufacturing