Scientist, Analytical Development

Bio Talent is partnered with an innovative regenerative biologics company looking to add an Analytical Scientist to their growing Process & Analytical Development team.

This is an opportunity to play a key role in the development of next-generation recombinant protein therapies, leading analytical method development and serving as a key technical interface with external CDMOs and CROs.

You'll work across CMC, process development and formulation teams to build and implement analytical strategies that support development from early-stage research through clinical and regulatory milestones.

• Developing, optimizing and validating analytical methods for recombinant protein characterization
• Leading protein analytics across purity, identity, potency and structural characterization
• Applying techniques including HPLC/UPLC (SEC, RP, IEX), CE-SDS, icIEF, LC-MS and spectroscopy methods
• Supporting formulation, process development and stability studies through analytical insight and data interpretation
• Managing assay transfers, qualifications and validations with external CDMOs and CROs
• Authoring technical reports, SOPs, validation protocols and CMC documentation
• Supporting IND/BLA submissions and regulatory interactions where required
• Collaborating closely with Process Development, Formulation, Quality and Manufacturing teams

• BSc or MSc in Analytical Chemistry, Biochemistry, Biotechnology or a related discipline, alongside relevant experience in the Biopharmaceutical industry
• Strong hands-on experience with protein characterization and analytical method development
• Expertise across chromatographic, electrophoretic and mass spectrometry-based techniques
• Experience with method qualification and validation within GMP/GLP environments
• Strong understanding of protein chemistry, aggregation, degradation pathways and post-translational modifications
• Familiarity with biologics CMC development and regulatory expectations (FDA, EMA, ICH)
• Previous experience in a biopharmaceutical or CDMO environment is highly desirable

This role would suit an analytical scientist who enjoys working in a fast-moving development environment and wants broad exposure across protein therapeutics, CMC development and external partner management.