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Project Manager, Analytical Development

Join the development team in a leading and fast growing biotech company

Ascendis Pharma is currently expanding its CMC resources to support the further clinical development of its TransCon Growth Hormone program and to initiate the clinical development phase of two new peptide programs. Moreover, the manufacturing processes in the TransCon Growth Hormone program are approaching the PPQ stage with associated analytical work packages. Ascendis Pharma is therefore looking to hire a passionate Project Manager within analytical development and chemistry to provide effective analytical support.

You will become responsible for the outsourcing of analytical development, method validation, and stability testing activities for Starting Materials and Intermediates in the late stage TransCon Growth Hormone project. You will also be involved in similar analytical tasks for the early stage development projects. Additionally, you will work to ensure continuous good relations and alignment with Contract Manufacturing Organizations (CMOs) worldwide and stay updated with insights into their methods and processes. You will join a CMC team of 4 organic chemists and 4 analytical chemists, and you will report directly to the Vice President CMC Drug Substance & Analysis.

Criteria of success in the role will be to establish reliable and robust analytical methods at the CMOs to support market supply of the TransCon Growth Hormone, to contribute actively within the CMC project teams regarding analytical challenges, and to 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:

  • Project management/coordination of analytical activities between CMOs and Ascendis Pharma as daily point of contact
  • Support the analytical team at CMOs and at the Ascendis Pharma Heidelberg facility with analytical troubleshooting
  • Discuss and monitor execution of the analytical validation strategies
  • Writing of regulatory documentation for the CMC part of INDs/IMPDs, and eventually for the registration file
  • Outline agreements and work orders for analytical tasks within Ascendis Pharma’s late stage development project together with Ascendis Pharma’s legal staff

You hold a relevant academic degree – preferably a Master of Science in Chemistry, Engineering, Pharmacy or the like. You have several years of documented practical analytical experience from the pharmaceutical industry within chromatographic analyses (HPLC/UPLC, LC-MS, SE-HPLC), either from an Analytical Development Laboratory or from a QC Laboratory. Furthermore, your knowledge and experience within the analytical chemistry field will enable you to guide project teams at CMOs placed in Europe, Japan, and USA 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 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 together 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 Partner, Jørn Duhn on M: +45 21 75 19 25. All applications must be submitted in English and are treated confidentially.

Ascendis Pharma A/S is an international company with offices in Copenhagen, Germany and the US. Ascendis Pharma is building an integrated biopharmaceutical company to advance its pipeline of longacting prodrug therapies. They employ their proprietary TransCon technology platform to generate therapeutics with best-in-class profiles that address large markets with significant unmet medical needs. Ascendis Pharma has a diversified and balanced high-value product pipeline, including internal programs and partnerships with market leaders.

Read more at www.ascendispharma.com

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