Overview
We are currently supporting an exciting opportunity for a Senior New Product Development Scientist to join a growing and dynamic Analytical Development team. This hands-on role offers the chance to lead method development, validation and transfer activities to support product formulation, stability testing and regulatory submissions. You will be working across the full product lifecycle, from early-stage development through to commercial release, providing technical expertise and practical solutions to ensure high-quality outcomes. The role also provides scope to mentor junior scientists and share your knowledge, while remaining focused on laboratory work and project delivery.
Key Responsibilities
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Independently develop, validate and transfer robust analytical methods, including dissolution, to support product release and stability testing.
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Perform physical and chemical testing on prototype formulations to assess stability and guide formulation decisions.
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Ensure all laboratory activities comply with GLP and GMP standards, maintaining full documentation, data integrity and quality records.
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Prepare and review analytical methods, specifications, validation reports, SOPs, COSHH assessments, and scientific protocols.
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Drive continuous improvement by identifying opportunities to optimise existing methods, processes, and products using the latest analytical techniques.
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Support regulatory submissions, providing data and documentation for CTD Module 3 and responding to regulatory queries as required.
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Troubleshoot and resolve complex analytical challenges, deviations and project issues.
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Collaborate closely with cross-functional project teams, contributing to technical discussions and project planning.
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Mentor junior colleagues, sharing knowledge and promoting best practice in analytical development.
Requirements
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Degree in a relevant scientific discipline or equivalent experience.
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Extensive experience in physical and chemical analytical techniques and associated software.
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Proven track record in developing, validating and documenting analytical methods within a regulated environment.
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Ability to work independently across multiple projects, prioritising effectively and delivering results.
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High standards of technical documentation, data integrity, and attention to detail.
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Exposure to GMP environments and regulatory submissions is highly desirable