We are seeking a highly skilled Scientist/Senior Scientist, Analytical Development to support the development of peptide-based programs. This individual will play a key hands‑on role in developing, optimizing, and implementing analytical methods used to characterize peptides, peptide conjugates, intermediates, and drug substances throughout development.
The ideal candidate brings deep expertise in HPLC/UPLC-based analytical development, strong knowledge of peptide chemistry and characterization, and the ability to troubleshoot complex analytical problems in a fast-moving research and development environment.
Responsibilities
- Develop, optimize, qualify, and troubleshoot analytical methods for peptides, peptide conjugates, intermediates, precursors, and related drug substances.
- Serve as a subject‑matter expert for HPLC and UPLC, with particular emphasis on reversed‑phase chromatographic methods for purity, identity, and related‑substance analysis.
- Characterize peptide products with respect to purity, identity, degradation products, impurities, stability, and other critical quality attributes.
- Use complementary analytical techniques including LC‑MS/MS, mass spectrometry, and other appropriate physicochemical characterization methods.
- Support analytical characterization of peptide synthesis, purification, and conjugation,
- Develop stability‑indicating methods and support formulation, forced‑degradation, and stability studies.
- Partner closely with chemistry, radiochemistry, process development, CMC, and other technical functions to interpret analytical data and guide program decisions.
- Investigate unexpected analytical results, impurity profiles, method‑performance issues, and product‑quality questions.
- Author analytical methods, protocols, technical reports, specifications, and development documentation.
- Support method transfer and technical oversight of external CRO/CDMO partners.
- Contribute to analytical strategies appropriate for progression from discovery and preclinical development toward IND‑enabling and GMP activities.
- Maintain high standards for data integrity, documentation, and laboratory safety.
Required Skills
- PhD in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline, with approximately 3+ years of relevant industry experience; or MS/BS with substantial directly relevant industry experience.
- Demonstrated expertise in the analytical development and characterization of peptides or peptide‑based therapeutics.
- Extensive hands‑on experience with HPLC and UPLC method development and troubleshooting.
- Experience with Waters HPLC/UPLC instrumentation and Empower software strongly preferred.
- Strong understanding of chromatographic method development, including gradients, columns, mobile‑phase selection, selectivity, resolution, and impurity separation.
- Experience with LC‑MS or other mass‑spectrometry‑based characterization of peptides.
- Understanding of peptide degradation pathways, related substances, chemical stability, and impurity profiling.
- Ability to independently design experiments, interpret complex datasets, troubleshoot methods, and communicate conclusions to multidisciplinary project teams.
- Strong written and verbal communication skills and the ability to operate effectively in a highly collaborative, fast‑paced environment.