Senior/Principal Scientist, Analytical Development & CMC

Biograil; Roskilde; Hybrid; DKK 700,000 - 900,000; Full time

Job summary

Biograil is a pre-clinical stage pharmaceutical company based in Roskilde, Denmark, advancing its BIONDD™ platform for oral delivery of peptides and biologics. The Senior/Principal Scientist will lead analytical development and CMC activities, supporting progression from research to clinical development.

You will work across DS/DP, collaborate with CDMOs and external labs, and help prepare CMC documentation and regulatory submissions.

Qualifications

• Master’s or PhD in chemistry, biochemistry, pharmacy, or related field.
• 5+ years’ experience in analytical method development/validation for biotherapeutics.
• Hands-on analytical characterization of peptides/biologics.
• Oral drug products experience considered an advantage.
• Strong understanding of cGMP requirements and regulatory guidelines.
• Experience in cross-functional project collaboration and partner interactions.
• Experience with CDMOs including tech transfer, validation and stability studies.
• Strong communication and stakeholder management skills.

Responsibilities

• Lead analytical development activities for BIONDD-based candidates across DS/DP, including method development, qualification, and release.
• Design and oversee analytical characterization and performance testing, including bioanalysis and release-relevant bioassays.
• Generate and interpret high-quality analytical CMC data packages to support progression from research into clinical development.
• Perform hands-on lab work and coordinate daily laboratory activities, while aligning with regulatory requirements.
• Collaborate with CDMOs, external labs and academic partners; oversee outsourced activities and GMP-aligned work.

Skills

Analytical method development

Validation

Biotherapeutics

cGMP compliance

Cross-functional collaboration

CDMOs coordination

Communication

Regulatory knowledge

Education

Master’s degree or PhD in chemistry, biochemistry, pharmacy, or related field

Job description

Biograil is a pre-clinical stage pharmaceutical company based in Roskilde, Denmark, advancing its BIONDD™ platform for oral delivery of peptides and biologics. The Senior/Principal Scientist will lead analytical development and CMC activities, supporting progression from research to clinical development.

You will work across DS/DP, collaborate with CDMOs and external labs, and help prepare CMC documentation and regulatory submissions.