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Project Manager CMC – Organic Chemist

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

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 our 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 comprise both classic organic chemistry, solid phase peptide synthesis (SPPS) and polymer chemistry. This position as Project Manager CMC is for Ascendis’ new development projects facing optimization and up-scaling to support clinical development.

You will be part of a team responsible for the chemical manufacture of Starting Materials, Intermediates, and Drug Substance in one or more of the development projects. Additionally, you will work to ensure continuous good relations and alignment with CMOs worldwide and stay updated with insights into their methods and processes. The CMC team consists of highly experienced CMC professionals (Organic Chemists and Analytical Chemists), and you will report directly to the Vice President of CMC Drug Substance & Analysis.

Criteria of success in the role will be to establish reliable and robust manufacturing procedures at the CMOs to support clinical supply for the development programs. Moreover, you must contribute actively within the CMC project teams regarding manufacturing challenges and establish close and high-standard collaborations with the CMOs that Ascendis Pharma works closely with and be a value-adding resource to them.

Main areas of responsibility:

  • Support CMOs with optimization of the chemical manufacturing processes
  • Establish reliable 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 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. Industrial experience after a Ph.D./Post.Doc. is a requirement for this position. A candidate with experience within up-scaling of manufacturing processes, and with out-sourcing of development and GMP manufacturing activities, will be preferred. 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 interpersonal 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, 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 work with highly skilled and experienced colleagues to advance our 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 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
Stamholmen 157
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
Søren Frichs Vej 42R
8230 Aabyhøj
Unique Human Capital Poland Sp. z o.o.
ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
Poland
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