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Project Manager, Analytical Development

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

Ascendis Pharma is expanding its CMC resources to support and mature its early development projects. We have just finalized recruitment of a new Analytical Development Project Manager for our late stage hGH project, and we are now looking to hire a passionate Project Manager within analytical development to provide effective analytical support to our early stage projects.

You will become responsible for supporting and outsourcing the analytical method development activities at Contract Manufacturing Organizations (CMOs) including method validation, release and stability testing activities for Starting Materials, Intermediates, API and DP. As our new Project Manager within the CMC Drug Substance & Analysis group, you will work to ensure continuous good relations and alignment with our CMOs worldwide and stay updated with insights into their analytical methods and manufacturing processes. You will join a team of nine highly experienced CMC professionals (4 organic chemists and 5 analytical chemists). The Project Manager, Analytical Development will report directly to the Vice President CMC Drug Substance & Analysis.

The success criteria in this role will be to establish reliable and robust analytical methods and to support analytical development activities at the CMOs/CROs. You will contribute actively within the CMC project teams regarding analytical challenges, and you will establish close and high-standard collaborations with the CMOs/CROs that Ascendis Pharma work with.

Main areas of responsibility:

  • Project management/coordination of analytical activities between CMOs/CROs and Ascendis Pharma as daily point of contact
  • Support the analytical team at CMOs/CROs 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 development projects together with Ascendis Pharma’s legal staff

You hold a relevant academic degree – preferably a Master of Science in Chemistry, Engineering, Pharmacy or similar. You have 4-7 years of documented practical analytical experience from the pharmaceutical industry within chromatographic analyses (HPLC/UHPLC, LC-MS, SEC), either from an Analytical Development Laboratory or from a QC Laboratory. Furthermore, you have a considerable interest in being involved in complex analytical chemistry where a great attention to detail is required. You thrive in an environment with a focus on collaboration and communication skills.

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 Senior Consultant, Partner Lifesciences Jørn Duhn, Unique Human Capital 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 ascendispharma.com

Kontakt
Unique Human Capital A/S
cvr: 31502705

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T +45 7020 6700
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Poland
T + 48 22 291 32 20