Great responsibility for peptide API manufacturing approaching commercial phase, within a cross-functional department including chemical and biologics manufacturing and QC functions
Ascendis Pharma is focused on building a leading rare disease company providing meaningful improvements in patients’ lives by developing best-in-class therapeutics addressing unmet medical needs by applying their TransCon technology platform.
Ascendis Pharma is looking for a science-driven Project Manager Chemical Manufacturing with development and manufacturing experience to support and optimize manufacturing processes in collaboration with contract manufacturing organizations (CMOs) for GMP manufacture of peptides and conjugated peptide APIs. The manufacturing processes comprise solid phase peptide synthesis (SPPS), peptide chemistry, conjugation, downstream and purification processes and polymer chemistry. This position as Project Manager Chemical Manufacturing is for projects having reached the stage of process qualification and commercial manufacturing.
You report directly to the Director Chemical Manufacturing and will be part of a very dedicated and experienced team.
Your main responsibilities are:
As Project Manager at Ascendis Pharma, the main criteria of success will be to establish commercial manufacturing processes at CMOs, 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 cross-functional project teams on challenges related to chemical processes and manufacture.
You hold a relevant academic degree preferably a Master of Science in Chemistry, Engineering, Pharmacy or equivalent.
The successful applicant will have several years of documented practical experience with chemical development and manufacture from the pharmaceutical industry within peptide chemistry, downstream processing, tech transfer, upscaling, risk assessments, process validation and manufacture under cGMP. In addition, you have experience with CMO oversight and continuous process monitoring programs. Your knowledge and experience within peptide chemistry and downstream processing field will enable you to guide project teams at CMOs mainly placed within Europe 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 collaborative environments. Strong interpersonal skills are necessary as your job is to establish good and productive collaboration with CMO’s. 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 Pharma’s exciting product pipeline.
Travelling: 10 - 15 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 Director Chemical Manufacturing Birgitte M. Malle on M +45 42 74 06 09 or email . All applications must be submitted in English and are treated confidentially.