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Project Manager CMC – Organic Chemist

Join the Chemical Development Team in a leading and fast-growing biotech company

Ascendis Pharma is focused on building a leading rare disease company providing meaningful improvements to patients by developing best-in-class therapeutics addressing unmet medical needs by applying its TransCon technology platform.

Ascendis Pharma is looking for a science-driven organic chemist with development experience to support and optimize the manufacturing processes for the development projects and provide effective support to the contract manufacturing organizations (CMOs) for GMP manufacture of starting materials, intermediates, and APIs. The manufacturing processes within the TransCon technology portfolio covers classic organic chemistry, solid phase peptide synthesis (SPPS), and polymer chemistry. This position as Project Manager CMC is within the current development projects portfolio facing optimization and up-scaling to support clinical development.

You will be part of a highly experienced and dedicated team consisting of 4 chemists who are responsible for the chemical development and manufacture of starting materials, intermediates, and drug substances. In addition to the scientific and CMC related tasks, you will strive to keep continuous good relationships and alignment with CMOs worldwide and stay updated with insights into their methods and processes.

Criteria of success in the position will be to establish reliable and robust manufacturing procedures at the CMOs to support clinical supply for Ascendis’ development programs. Moreover, you must contribute actively within the CMC project teams regarding manufacturing challenges.

Main areas of responsibility:

  • Support the CMOs with optimization of the chemical manufacturing processes
  • Establish reliable and robust manufacturing processes for GMP manufacture
  • Coordination of optimization and manufacturing activities between CMOs and Ascendis Pharma as daily point of contact
  • In collaboration with the CMOs you will document the process development, establish master batch records, and together with the QA organization review executed batch records for batch release
  • Writing of regulatory documentation for the CMC part of INDs/IMPDs, and eventually for the registration file

You hold a relevant academic degree – preferably a Ph.D. in Chemistry, Engineering, Pharmacy, or equivalent. You have at least 2-5 years of experience within the field of organic chemistry from the pharmaceutical industry. Preferably, you have experience with up-scaling of manufacturing processes, out-sourcing of development and GMP manufacturing activities. Furthermore, your knowledge and experience within the organic chemistry field will enable you to guide project teams at CMOs through conceptual as well as specific practical discussions.

You are proficient in English at a professional level, both written and spoken.

You are a highly motivated individual who enjoys being challenged and working in collaborative environments. Strong interactive skills are necessary as you will serve as a major contributor and trusted member of the project development teams. A proven ability to communicate with other development staff in a fast-paced environment is crucial. Finally, the ability to think holistically and manage strategically decisions 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 work with highly skilled and experienced colleagues to advance the exciting product pipeline.

Travelling: 10-20 days per year.

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbor, the canals, and the sea.

For more details about the job or the company, please contact Partner Jørn Duhn, Unique Human Capital on M +45 21 75 19 25 or 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.

Unique Human Capital A/S
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cvr: 31502705
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9000 Aalborg
Søren Frichs Vej 42R
8230 Aabyhøj
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