Join the Drug Product Manufacturing team in an innovative and fast-growing biotech company
Ascendis Pharma is currently expanding to support activities within our TransCon technology. The TransCon Growth Hormone program is in the PPQ phase rapidly approaching the commercial phase and other programs are in late development. Therefore, for our outsourced QC activities Ascendis Pharma is hiring a Senior Scientist to provide effective analytical support to QC of our large molecule drug product.
You will contribute with a high level of knowledge about analytical testing. You will participate in all aspects of QC testing at our CMOs including validation, trouble shooting, optimization and transfer of methods. You will work closely together with our CMOs as well as stakeholders within Ascendis Pharma to secure progression of our TransCon projects. For our products in late development you will work together with our CMC organization to secure a smooth transfer of responsibility from Development to Product Supply. You will join a team of highly experienced colleagues and you?will report to the Director of Drug Product QC.
Your main responsibilities are:
Criteria of success in the role will be to ensure that analytical activities are executed in a scientifically sound manner and in accordance with regulatory requirements while continuously ensuring good relations and alignment with CMOs and other stakeholders.
You hold a relevant academic degree preferably a Master of Science in Pharmacy, Chemistry, Engineering, or the like. You have several years of analytical experience from the pharmaceutical industry within chemical analysis, either from an Analytical Development Laboratory or from a QC Laboratory. It will be an advantage if you have experience with or knowledge of other analytical methods than chemistry based and if you have experience with setup of stability programs including trending and data handling. Furthermore, your knowledge and experience within the analytical field is expected to enable you to give input to project teams at CMOs through conceptual as well as specific practical issues and discussions. Preferably, you have analytical experience with analysis of large molecules, incl. polymers, proteins and/or peptides.
You are proficient in English at a professional level, both written and spoken. As the job involves many stakeholders and some coordination of activities both internally and externally, you thrive with being in contact with new people. Experience with Lean and systematic problem-solving tools is an advantage.
As thejob involves many stakeholders and some 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. You have excellent abilities in terms of keeping an overview even with many active tasks at the same time. You have a positive mind-set, are a team player, but can work independently as well as you have organization and planning skills.
Ascendis Pharmaoffers you an exciting and challenging position in an entrepreneurial and international company with a short line of command, and you will have the chance to make your mark on an evolving organization. You will be involved in getting Ascendis Pharma to become a pharmaceutical company with commercial production and will work with highly skilled and experienced colleagues within the Drug Product manufacturing disciplines.
Travelling: Approx. 10-15 days per year.
Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in H