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Ascendis Pharma, a global biopharmaceutical company, is seeking a Reference Standard Specialist to join its growing team at the headquarters in Hellerup, Denmark. This role serves as the point of contact for reference standard matters between Ascendis Pharma and Contract Manufacturing Organizations (CMOs) on specified projects.
You will work to ensure continuous good relations and alignment with CMOs worldwide, staying updated on their methods and processes in collaboration with QC specialists. The role involves contributing to analytical testing, test methods, and regulatory guidelines and requirements on reference standards.
Key responsibilities include:
- Planning, coordinating, and documenting activities regarding establishment, maintenance, re-supply, recalibration, and distribution/shipping of reference standards and critical analytical substances
- Establishing and maintaining an overview of reference standards for all purposes and product phases (development and commercial manufacturing), including storage location, stock, stability, and expiry dates
- Establishing and maintaining internal guidance (SOPs or guides) for reference standards
- Ensuring relevant updates of external legislation and guidelines for reference standards are implemented in the Ascendis Pharma Quality Management System
- Contributing as an author on regulatory documents such as IMPDs, INDs, NDAs, and BLAs, and providing answers to questions from authorities in writing or face-to-face during inspections
- Contributing to assessment of inspection readiness of CMOs
You will report directly to the Associate Director for Reference Standards and work within a small team of highly experienced colleagues in a fast-paced environment, collaborating with cross-functional, global teams. Travel is expected up to 10 days per year.
Qualifications and Requirements:
- Relevant academic degree, preferably a Master's in Pharmaceutical Sciences, Chemistry, Engineering, or other relevant education
- Minimum 5 years of experience from Biotech or Pharmaceutical industry working with reference standards
- Knowledge and experience within the reference standard area to guide project teams at CMOs through conceptual and practical discussions
- Experience with coordination of reference standard activities and commercial setup for resupply of reference standards
- Advantageous: experience with analysis of large molecules, polymers, proteins, and/or peptides
- Advantageous: knowledge and practical experience in analytical sciences (chromatographic analyses such as HPLC and bioassays) from analytical development or QC laboratories
- Structured and systematic approach to solving tasks
- Outstanding skills in collaboration and communication
- Ability to maintain overview with many active tasks simultaneously
- Strong team player with analytical mindset and can-do attitude
- High energy level and focus on details
