Reference Standard Specialist

Do you have experience with Reference Standards and are you passionate about creating a broad collaboration with Contract Manufacturing Organizations and internal stakeholders? Ready for your next career move? If so, now is your chance to join Ascendis Pharma as our new Reference Standard Specialist. Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients’ lives. Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs. At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets. We are seeking a passionate Reference Standard Specialist to join our growing team. As a key member of the Reference Standard team, you will become point of contact in 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 and stay updated with insights into their methods and processes together with our QC specialists. It is expected that in the collaboration you will contribute to areas such as analytical testing and test methods as well as regulatory guidelines and requirements on reference standards. This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results. Your typical workday will consist of discussions and support together with a small team of highly experienced colleagues. You will report directly to Therese Lindin, Associate Director for Reference Standards,who is based in Hellerup, and you will also be working at our headquarters in Hellerup. Your

key responsibilities
will be:
- Plan, coordinate and document activities regarding establishment, maintenance, re-supply, recalibration and distribution/shipping of reference standards and critical analytical substances
- Establish and maintain overview of reference standards for all purposes and product phases (development and commercial manufacturing) including storage location, stock, stability, expiry etc. for current standards as well as standards needed in the future to ensure availability of required standards
- Establish and maintain internal guidance (SOP or guides) for reference standards
- Make sure relevant updates of external legislation and guidelines for reference standards are implemented in the Ascendis Pharma QMS
- Contribute as an author on regulatory documents, such as IMPD’s, IND’s, NDA’s and BLA’s and provide answers to questions from authorities – in writing or face to face during inspections. Further, contribute to assessment of inspection readiness of CMO’s. Qualifications and

Skills:
You hold a relevant academic degree – preferably a masters in Pharmaceutical Sciences, Chemistry, Engineering, or other relevant education – and a minimum of 5 years of experience from Biotech or Pharmaceutical industry working with reference standards. Your knowledge and experience within the reference standard area will enable you to guide project teams at CMOs through conceptual as well as specific practical discussions. You have experience with coordination of reference standard activities, and experience with the commercial setup for resupply of reference standards. It will be an advantage if you have experience with analysis of large molecules, and preferably with polymers, proteins and/or peptides as well. Furthermore, knowledge and practical experience in analytical sciences from the pharmaceutical industry within chromatographic analyses (HPLC) and bioassays, either from an analytical development laboratory or from a QC Laboratory will be an advantage. Key competencies: You have a structured and systematic approach to solving tasks and possess outstanding skills in collaboration and communication. As the job involves many stakeholders and coordination of activities both internally and externally, you thrive with being in contact with new people. You are a highly motivated individual who enjoys being challenged and working in collaborative environments. You possess a high energy level and focus on details. To succeed in this role, we also expect you to have excellent abilities in terms of keeping an overview even with many active tasks at the same time. You are a strong team player, analytical, and have a can-do attitude. Criteria of success in the role will be to ensure efficient coordination of reference standard activities for development projects as well as post-approval resupply a