Senior Project Manager Commercial Manufacturing
Great Influence on a Newly Established Department
As Senior Project Manager at Ascendis Pharma, the main criteria of success will be to establish procedures for monitoring the commercial chemical manufacturing processes, drive post PPQ activities and to establish close and high-standard collaborations. In addition, you will be a value-adding resource, actively contributing within the PS project team on challenges related to chemical processes and manufacture.
You report directly to the Senior Director Chemical Manufacturing and will be part of a very dedicated and experienced team.
Your main responsibilites are:
- Establishment of continuous process monitoring & verification programs at Ascendis for commercial manufacture at CMOs
- Coordination of commercial manufacture
- Post PPQ optimization of manufacturing processes
- Support QA during master batch record updates and release of commercial batches
- Trouble shooting activities at CMOs
- Prepare and make Ascendis and CMOs ready for authority inspections, regarding manufacturing processes and documentation
- Writing of regulatory documentation for marketing approval
You hold a relevant academic degree – preferably a Master of Science in Chemistry, Engineering, Pharmacy or the like.
The successful applicant will have several years of documented practical experience with chemical development and manufacture from the pharmaceutical industry within upscaling of chemical processes, risk assessments, PPQ and manufacture under cGMP. In addition, you have experience with commercial manufacture and continuous process verification. Your knowledge and experience within the process chemistry field will enable you to guide project teams at CMOs mainly placed within Europe and Asia through conceptual as well as specific practical discussions.
You are proficient in English at a professional level, both written and spoken, and you master MS Office. Experience with MS Projects or other project tools is an advantage.
You are a highly motivated individual who enjoys being challenged and working in a collaborative environment. Strong interpersonal skills are necessary as your job is to establish good and productive collaboration with CMOs. A proven ability to communicate with other development staff in a fast-paced environment is crucial. Finally, an ability to think and manage strategically with attention to detail is a prerequisite, as well as a high energy level, focus, and a passion and sense of urgency for developing important new medicines for devastating diseases.
Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and you will work with highly skilled and experienced colleagues to advance Ascendis’ exciting product pipeline.
Travelling: 20 – 30 days/ year
Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals and the sea.
For more details about the job or the company, please contact Research Consultant Elisabeth Haun, Unique Human Capital on M +45 28 90 33 88. All applications must be submitted in English and are treated confidentially.