Senior Research Scientist - Peptide Analysis & Analytical Development

Develop, optimize, and apply analytical methods based on a range of separation and detection techniques — including LC-MS/MS, SEC-UV, HPLC-UV/DAD, 2D-LC-MS for the characterization of peptide drug substances and complex drug products, such as lipid-based systems.

Develop and oversee the use of complementary physicochemical techniques (e.g. CD Spectroscopy, DLS, NMR) to support higher-order structural characterization and aggregation assessment of peptides.

Degradation & Impurity Profiling

Design and execute stability and forced degradation studies to systematically identify degradation pathways (hydrolysis, oxidation, deamidation, racemisation, aggregation) under long-term storage and stress conditions.

Characterize and structurally elucidate degradation products and process-related impurities using mass spectrometry and other orthogonal methods.

Build and maintain comprehensive impurity profile knowledge for peptide APIs and formulated products in support of ICH Q3A/Q3B and Q6B specifications.

Stability Studies

Set up, manage, and provide scientific conclusions and recommendations based on stability data (from real-time, accelerated, and stress studies) for peptide drug substances and formulations, to guide formulation development and define shelf-life.

Identify and investigate stability-indicating attributes and develop stability-indicating analytical methods.

CMC & Regulatory Support

Author and critically review analytical sections of CMC regulatory dossiers for IND/CTA and NDA/MAA submissions.

Respond to regulatory agency questions on analytical matters and support pre-submission meetings where relevant.

Collaboration & Scientific Leadership

Collaborate cross-functionally with formulation scientists, pharmaceutical development, quality assurance, and manufacturing colleagues in project teams.

Act as the analytical science expert for assigned drug development projects, contributing to strategic decisions on characterization and testing approaches.

Keep up to date with advances in peptide analytical science, regulatory expectations, and industry best practices.

Ph.D. in analytical chemistry, pharmaceutical chemistry, medicinal chemistry, or a closely related discipline.

Minimum 5 years of post-doctoral or industrial experience in analytical development, with a focus on peptides or biopharmaceuticals.

Advanced hands-on expertise in chromatographic and hyphenated techniques for peptide analysis: RP-HPLC/UHPLC, LC-MS/MS, and HPLC-UV/DAD, including method development and validation.

Demonstrated experience analyzing peptides in complex or non-aqueous formulation matrices (e.g. lipid-based, semi-solid, or depot systems).

Strong understanding of peptide degradation chemistry and proven experience designing and interpreting forced degradation and impurity profiling studies.

Experience setting up and interpreting stability studies in accordance with ICH Q1A–Q1F guidelines.

Track record of contributing to CMC analytical sections of regulatory dossiers (IND/CTA or NDA/MAA), with solid working knowledge of relevant ICH guidelines.

Experience working in structured, cross-functional project teams with demonstrated ability to deliver results independently.

It is advantageous if you also have any of the following:

Experience with structural characterization of peptides in complex matrices by e.g. high-resolution mass spectrometry.

Familiarity with complementary biophysical techniques: CD spectroscopy, DLS, SEC-MALS, or solid-state characterization methods.

Experience with analytical method transfer to QC laboratories or CMOs.

Exposure to GMP analytical environments.

Familiarity with statistical tools for analytical data treatment and data integrity principles (21 CFR Part 11 / EU Annex 11).