Description
Are you passionate about analytical chemistry? Do you thrive in a collaborative environment that spans functions and cultures? If so, now is your chance to join the Drug Product QC team in an innovative and fast-growing biotech company as our new Senior Specialist. Ascendis Pharma is a fast-growing global biopharmaceutical company committed to making a meaningful difference in patient’s lives. We have locations in Denmark, Germany, the United States, the UK, Italy, Spain, and France.Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs.Today, we are advancing programs in Endocrinology Rare Disease and Oncology.
In addition, we collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets.We are seeking an experienced Senior Specialist to join our growing team. As a key member of the Ascendis Pharma QC team, you will play a central role in coordinating analytical matters between Ascendis and different Contract Manufacturing Organizations (CMOs) as well as establishing and maintaining oversight over stability studies. You will be involved in all aspects of QC testing and handling of stability studies at our CMOs including validation, trouble shooting, trending and optimization.
As we are currently submitting our products in many countries preparing regulatory documentation and answering questions from different authorities will be a part of the job. So, the success criterion in the job will be to ensure continuous good relations and alignment with CMOs and to ensure that analytical activities are executed according to regulatory requirements and in a scientifically sound manner. You will join the Drug Product QC team of five colleagues and report to Senior Director Lars Bo Ekhart Jensen, based in Hellerup.
Your key responsibilities will be:
- Oversight and coordination of analytical activities at the CMOs
- Support the CMOs in decisions regarding the analytical methods e.g. validation strategy, laboratory investigations, method optimization.
- Give input or participate directly with the CMO in trouble shooting in connection with adverse events in the laboratory
- Planning and follow up on projects initiated at the CMOs
- Facilitate and support analytical performance and efficiency improvements
- Review and approve analytical documents e.g. laboratory investigations, validations, protocols, reports, and deviations
- Support regulatory documentation, follow-up on post-approval commitments and answering regulatory questions on method- and stability related aspects to the authorities
- Support our partners in different countries in preparing submission packages for the local authorities
- Stay updated with scientific and regulatory development in areas of analytical testing, analytical methods, analytical validation, and stability testing
- Contribute to establishing a strong QC organization within Ascendis Pharma
Qualifications and Skills:
- You hold a relevant academic degree – preferably a Master of Science in Chemistry, Engineering, Pharmacy or the like
- You have at least 8 years of experience from the pharmaceutical industry within chemical analysis, especially chromatographic methods (HPLC/UPLC, LC-MS, SE-HPLC), either from an Analytical Development Laboratory or from a QC Laboratory.
Furthermore, it is an advantage if you have experience with:
- Collaboration and communication with external stakeholders enabling you to guide project teams at CMOs through conceptual as well as specific practical discussions.
- Management of stability programs, generation of protocols and reports, sample management and compilation of results
Key personal competencies:
You are a strong team player and have a can-do attitude. You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key. To succeed in this role, we expect you to be structured and systematic in your approach to solving tasks. As the job involves many stakeholders and coordination of activities both internally and externally, you thrive on being in contact with new people and you are proficient in English, both written and spoken. You know how to maintain a constructive working environment and are used to work with stakeholders to support product supply programs and ensure adherence to project timelines.
You enjoy having a broad network and know how to secure an acceptable compliance level at CMOs with different approaches to GMP. You enjoy sharing knowledge and participating actively in projects and cross functional meetings. You are used to establishing overviews, preparing and following plans, and finding smarter ways of doing things are key goals for you. Travel: 5-15 days per year. Office: Denmark, Tuborg Boulevard 12, 2900 Hellerup Apply now Applications will be evaluated when received, so please apply as soon as possible. All applications must be submitted in English and are treated confidentially. For more details about the position or the company, please contact Lars Bo Ekhart Jensen, Sr.
Director, +45 3080 5829, lbej@ascendispharma.com, or visit our website www.ascendispharma.com
