Senior Scientist / Principal Scientist – Analytical Development & CMC

Biograil; Roskilde; Hybrid; DKK 700.000 - 900.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Analytical method development

Validation

Biotherapeutics

cGMP compliance

Cross-functional collaboration

CDMOs coordination

Communication

Regulatory knowledge

Ausbildung

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

Jobbeschreibung

Senior Scientist / Principal Scientist – Analytical Development & CMC

Biograil is expanding its Pharmaceutical Research organization and is seeking an experienced Analytical Scientist to drive analytical development and CMC activities for our proprietary BIONDD™ oral delivery platform for peptides and biologics.

You will play an important role in analytical development across drug substance, drug product, and combination product development, supporting our ambition to advance next‑generation orally delivered biotherapeutics.

The Role

As our new colleague, you will contribute scientific expertise to analytical development, participate in cross‑functional project teams, and collaborate closely with internal and external stakeholders. Depending on experience, the position can be offered at Senior Scientist or Principal Scientist level. You will report to the Senior Director Pharmaceutical Research.

Responsibilities

In this role, you will lead analytical development activities for BIONDD™‑based candidates across drug substance, drug product, and combination product development, including method development, qualification, and validation for batch release. You will design and oversee analytical characterization and performance testing, including bioanalysis and release‑relevant bioassays, and establish robust analytical testing strategies for peptides and biologics, including antibodies, both internally and through external laboratories. You will generate and interpret high‑quality analytical CMC data packages that support progression from research into clinical development and inform project decisions. You will also perform hands‑on laboratory work and coordinate daily laboratory activities with colleagues.

You will share your scientific expertise and support colleagues within analytical development and CMC, bring an analytical and data‑driven perspective to cross‑functional project teams, and communicate progress, risks, and data interpretations clearly to management. You will stay current with regulatory requirements, including DS/DP quality expectations and applicable cGMP guidelines across development stages.

You will collaborate closely with external stakeholders such as CDMOs, external laboratories, and academic partners, overseeing analytical activities, critically evaluating data, and representing Biograil as the analytical CMC subject matter expert in partner interactions. You will support outsourced and GMP‑aligned activities, including method transfer, validation, qualification, and supplier collaboration. Within our Quality Management System, you will prepare, review, and approve SOPs, change requests, deviations, and quality records.

A key part of your role will involve preparing high‑quality analytical documentation, including method descriptions, validation reports, CMC summaries, and presentations for internal decision‑making and partner discussions, as well as contributing to regulatory submissions such as Pre‑IND/IND and IMPD/CTA packages. You will also contribute to the development of Biograil’s patent portfolio.

Professional Qualifications

• A master’s degree or PhD in chemistry, biochemistry, pharmacy, or a related field
• 5+ years’ experience in analytical method development and validation for biotherapeutic DS/DP within biotech or pharma
• Hands‑on experience with analytical characterization of peptides and/or biologics
• Experience with oral drug products is considered an advantage
• Solid understanding of cGMP requirements, DS/DP quality expectations, and analytical regulatory guidelines
• Experience in cross‑functional project collaboration and partner interactions
• Strong experience collaborating with CDMOs, including method development, tech transfer, validation, stability studies, and specifications
• Strong communication and stakeholder management skills

About You

You thrive in a dynamic, collaborative environment and enjoy driving analytical excellence. You are proactive, scientifically curious, structured, and able to communicate clearly across functions. You build trust, take ownership, and contribute positively to a strong team culture.

We Offer

• A key role with influence on analytical strategy and development direction
• Collaboration with a dedicated and highly skilled research organization
• An opportunity to shape analytical processes around an innovative oral delivery platform
• A friendly, ambitious work environment built on trust, innovation, and teamwork

About Biograil

Biograil is a pre‑clinical stage pharmaceutical company based in Roskilde, Denmark, with a mission to transform injectable medicines into convenient oral capsules. Our proprietary BIONDD™ platform is designed to enable oral delivery of biologics, from peptides to antibodies and RNAs, that today can only be given by injection. Join us and help shape the future of how patients receive biotherapeutics.

For questions about the position, please contact Anne Tungelund Larsen, Senior Director Pharmaceutical Research, [e-mail]