We are seeking a Senior Research Scientist in analytical chemistry to join our Pharmaceutical Research & Early Development team in Lund. In this role, you will play a key part in our CMC activities, applying advanced analytical methods that underpin the characterization, stability, and regulatory approval of peptide drug substances and formulations.
You will apply advanced analytical expertise to characterize complex peptide molecules and their formulated products, including those based on Camurus’ proprietary FluidCrystal® lipid-based delivery technology. This is a unique opportunity to contribute to the development of next-generation therapies that have a direct impact on clinical-stage programs.
The Role
Analytical Method Development & Characterization
- 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.
Your Profile
We are looking for a detail-oriented, scientifically driven analyst who delivers high-quality data. You confidently lead analytical investigations, communicate findings clearly, and translate complex results into actionable insights. You take ownership of your work and are motivated to advance novel peptide therapies to patients.
This role requires:
- M.Sc. or 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).
What We Offer
This is a great time to join a highly dynamic company during a very exciting phase of growth. The position offers an international work environment and corporate culture, with the possibility for individual development and growth. The corporate culture is driven by our core values of innovation, collaboration, ownership, quality, and passion for realizing our patient-centric commitment.
Application
This is an immediate, full-time employment opportunity. The selection process is ongoing, so submit your application as soon as possible, and no later than 30 August. Please attach your CV and a cover letter describing your motivation and the expertise you bring to this role. Please note that we do not accept applications by e-mail.
Read more about how Camurus will process your personal data here.
We are looking forward to seeing your application!
