Senior Analytical Development Scientist – Biotherapeutics

Biograil; Roskilde; Vor Ort; DKK 673.000 - 897.000; Vollzeit

Benefits dieser Stelle

Influence on analytical strategy

Collaborative research environment

Shape processes around oral delivery平台

Trust, innovation, teamwork culture

Zusammenfassung

Biograil in Roskilde, Denmark, is expanding its Analytical Science group and seeks an experienced Analytical Scientist to lead analytical development and CMC activities for the BIONDD™ oral delivery platform. You will advance DS/DP development, method development, qualification, and validation.

Depending on experience, the role can be Senior or Principal Scientist, reporting to the Senior Director Pharmaceutical Research.

Qualifikationen

• 5+ years’ experience in analytical method development and validation for biotherapeutic DS/DP
• Hands-on experience with analytical characterization of peptides and biologics
• Experience with oral drug products
• Solid understanding of cGMP requirements and regulatory guidelines
• Experience in cross-functional project collaboration and partner interactions
• Strong communication and stakeholder management skills

Aufgaben

• Lead analytical development across DS/DP and combination products, including method development, qualification, and validation for release.
• Design and oversee analytical characterization, bioanalysis, and release‑relevant bioassays for peptides and biologics.
• Prepare high‑quality CMC data packages to support progression to clinical development and regulatory submissions.
• Coordinate daily lab activities and communicate progress, risks, and data interpretations to management.

Kenntnisse

Analytical method development

Validation

Bioanalysis

Cross-functional collaboration

Stakeholder management

Regulatory understanding

Ausbildung

Master’s degree or PhD in chemistry/biochemistry/pharmacy

Jobbeschreibung

Biograil in Roskilde, Denmark, is expanding its Analytical Science group and seeks an experienced Analytical Scientist to lead analytical development and CMC activities for the BIONDD™ oral delivery platform. You will advance DS/DP development, method development, qualification, and validation.

Depending on experience, the role can be Senior or Principal Scientist, reporting to the Senior Director Pharmaceutical Research.