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Senior Analytical Development Scientist
- portsmouth, hampshire, PO1 3BG, United Kingdom
- Contract
- Full time
- £57,000 - £57,000 Per Annum
Job Description
About the Role
Our client is looking for a highly skilled Senior Analytical Development Scientist to join their growing team in Portsmouth . This role is essential for establishing and validating robust analytical methods required for the characterization and quality control of new pharmaceutical products. You will be instrumental in ensuring the quality, safety, and efficacy of our client's drug candidates through rigorous analytical testing. This position offers a significant opportunity to contribute to innovative drug development programs and work within a highly collaborative and science-driven environment, focused on delivering high-quality therapeutics.
Key Responsibilities
- Develop, optimize, and validate analytical methods for small molecules and/or biologics, including HPLC, UPLC, MS, GC, and spectroscopic techniques.
- Characterize drug substances and drug products, defining critical quality attributes (CQAs) and specifications.
- Perform stability studies and investigate out-of-specification (OOS) results.
- Transfer analytical methods to Quality Control (QC) laboratories and contract manufacturing organizations (CMOs).
- Author development reports, validation protocols, and validation reports for regulatory submissions.
- Collaborate with formulation development, process development, and regulatory affairs teams in Portsmouth .
Requirements
- MSc or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline.
- Minimum of 5 years of experience in analytical method development within the pharmaceutical industry.
- Extensive hands-on experience with chromatographic techniques (HPLC, UPLC, GC) and associated detectors.
- Proficiency in using various analytical software (e.g., Empower, Chromeleon).
- Strong understanding of ICH guidelines and regulatory requirements for analytical method validation.
- Excellent problem-solving abilities and meticulous attention to detail, crucial for analytical work in Portsmouth .
Benefits
- Competitive salary and performance-related incentives.
- Comprehensive healthcare coverage including medical, dental, and vision.
- Company pension plan.
- Generous holiday allowance and paid sick leave.
- Support for continuous professional development and training.
- A modern, well-equipped laboratory environment in Portsmouth .