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:
Qualifications and Skills:
Furthermore, it is an advantage if you have experience with:
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
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Are you excited about the world of analytical chemistry? If you find joy in working collaboratively across various functions and cultures, becoming a Senior Specialist in Drug Product QC at Ascendis Pharma might be your next big adventure! Ascendis Pharma is a rapidly expanding global biopharmaceutical company dedicated to making a meaningful impact in the lives of patients. With locations stretching from Denmark to the United States, we are guided by our core values of Patients, Science, and Passion as we develop innovative therapies using our TransCon® drug development platform. In this crucial role, you will coordinate analytical activities with our Contract Manufacturing Organizations (CMOs), helping ensure they align with regulatory requirements while maintaining scientific integrity. Your responsibilities will include overseeing analytical testing processes at our CMOs, troubleshooting laboratory events, and reviewing essential documents such as protocols and reports. In doing so, you will foster strong relationships with our partners and support the preparation of regulatory submissions and responses. To thrive, you'll need a Master’s degree in a relevant field and at least 8 years of pharmaceutical industry experience, primarily with chemical analysis and chromatographic methods. We're looking for a proactive team player with an entrepreneurial spirit who thrives in dynamic environments. If you're ready to contribute to a forward-thinking organization that values innovation, we invite you to apply and join our friendly Drug Product QC team, reporting to Senior Director Lars Bo Ekhart Jensen.
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