Job Title
Senior or Principal Analytical Scientist (Small Molecules)
About Saniona
Saniona is a clinical-stage biopharmaceutical company based in Glostrup, Denmark, dedicated to discovering and developing innovative treatments for rare diseases within the CNS area. With a strong focus on small molecule therapeutics, we advance programmes from preclinical research to clinical development. Our lean and agile team collaborates closely with a global network of partners and experts to drive our development programs forward in an efficient manner. At Saniona, skilled employees are given responsibility and the opportunity to shape processes and drive projects forward in a fast-paced environment but still with a quality mindset. We combine scientific excellence with a purpose-driven mission to improve the lives of patients with unmet medical needs. Join us in shaping the future of rare CNS disease treatment.
The Role
We are looking for an experienced and proactive Senior or Principal Analytical Scientist to lead and take scientific ownership of all analytical development activities for our pipeline of early phase small molecule drug candidates. In this key role, you will be the primary driving force behind the analytical support both within drug substance and drug product development activities together with an external consultant.
As a central member of our project teams, you will apply your deep Analytical and CMC Development expertise to advance development programs in an externalized “preferred partner” setup. We are looking for a candidate with a proactive attitude but also with a detailed, analytical systematic and scientific strong mindset, who thrives in a dynamic environment and is capable of handling a wide range of analytical development CMC tasks together with our Drug substance and Drug Product specialist and our external Analytical consultant.
Key Responsibilities
- Strategy and Leadership of Analytical Development:
- Lead the external analytical method development, optimization and validation across analytical techniques for small molecule programs in preclinical and clinical development within both the drug substance and drug product area together with our external analytical consultant.
- Act as the scientific representative for analytical development in cross-functional project core teams and actively contribute to the overall project strategy.
- Oversee, manage and build relationships with CMO counterparts in compliance with quality standards (SOP’s, GMP etc.) including delivering feedback and holding partners to timelines and deliverables while maintaining strong professional relationships.
- Application of Advanced Technologies:
- Apply advanced “analytical technologies” from our partners where necessary to generate the necessary data sets to support our development projects.
- CMC Development and Regulatory Documentation:
- Secure the development, verification or validation of relevant analytical methods for Drug Substances and Drug Product development in close collaboration with CDMOs and other relevant stakeholders.
- Review, analyze, document and present data from Partners, ensuring accuracy and compliance with regulatory standards (e.g. ICH guidelines, GMP).
- Prepare and compile the analytical CMC sections of Investigational Medicinal Product Dossiers (IMPDs) for clinical trial applications together with colleagues and consultants.
- Ensure that all analytical development and analytical control testing comply with GMP guidelines and internal and regulatory quality requirements.
- External Collaboration and Partner Management:
- Manage collaborations with our external preferred and new partners and act as the primary analytical contact person.
- Participate in the management and identification of new partners when needed to solve the required analytical CMC issues.
- Plan, monitor, and review outsourced analytical activities to ensure deliverables meeting Saniona’s standards and timelines.
- Be prepared for occasional international travel (primarily within Europe and Asia).
Qualifications & Experience
- Ph.D. or Master’s degree (MSc) in pharmacy, chemistry, or a related field.
- Minimum 10 years of experience in the pharmaceutical industry with a significant focus on analytical development and broader CMC development.
- Solid experience with the development of small molecule drugs up to Phase 1/2.
- Documented success in analytical development, including practical experience with “analytical methodologies” for small molecules.
- Broad understanding of the entire CMC area, including Drug Substance/Drug Product development and quality control.
- Experience in preparing CMC content for regulatory submissions (IMPD, IND, or similar).
- Extensive experience in managing external partners and CDMOs.
- Proactive, independent, analytical and detail oriented. Thrives in a small-company environment, taking initiative and adapting to a broad scope of responsibilities and changing priorities.
- Fluent in English (both written and spoken) with strong communication skills.
Compensation & Benefits
- A competitive salary package that reflects your qualifications and experience.
- A key role with direct and visible impact on project success.
- A broad and cross-functional role that provides exposure to all aspects of CMC Phase I and II drug development.
- A dynamic and collaborative work environment with skilled colleagues and international partners.
- High degree of autonomy and responsibility in an environment that values initiative.
- Flexible working conditions with the possibility of occasional remote work.
- A role in the CMC team, where you actively participate in crucial decision making for the projects.
Why you should join:
- Direct Impact and Autonomy: Be part of biotech company where we are building up a development organization to be able to handle an interesting pipeline of small molecule development programs is preclinical and clinical development. You are a central driving force that participate in shaping the CMC strategy and sees the direct effect of your work.
- Scientific Breadth and Development: Get a unique opportunity to work across the entire CMC spectrum – from preclinical to Phase I/II clinical development. Besides this you will work closely together with the entire Saniona project team.
- Complex Scientific Challenges: Work with advanced “analytical technologies” where relevant to solve complex CMC challenges.
Application Process
For further information about this exciting opportunity, or to apply, please contact Uta Talkenberg at Black Swans Exist. We process applications on an ongoing basis and look forward to hearing from you.
