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Director Downstream Manufacturing

Make a difference in a fast growing biotech company

As Director Downstream Manufacturing at Ascendis Pharma the main success criteria is to participate in building up the function in Product Supply, to assure a smooth tech transfer from Development to Commercial Manufacturing and to establish close and high-standard cooperation with the CMOs used by Ascendis Pharma.

The Director Downstream Manufacturing reports to the Senior Director Drug Substance Manufacturing and will be part of a very dedicated and experienced team.

For a Phase 3 project, the Director will be drug substance responsible (downstream) for the commercial manufacturing process and will be responsible for outlining pre-launch activities, post PPQ activities at the CMOs’ manufacturing intermediates and drug substance. You will use your experience within the fields of biological drug substances as well as late-stage development to guide and drive the process for having drug substance manufacturing performed in a timely manner.

The main responsibilities are:

  • Scientific lead of the biological drug substance manufacturing of intermediates and drug substance
  • Responsible for defining pre-launch activities and leading post PPQ activities such as scale-up/tech transfer/CPV
  • As daily point of contact, you will be responsible for project management/coordination of drug substance manufacturing activities between CMOs and Ascendis Pharma
  • Responsible for downstream purification activities at the CMOs, including follow up on production metrics and optimization projects
  • Involved in writing regulatory documentation for the NDA/MAA
  • Support inter-departmental communication and ensure effective hand-offs to execute on important project milestones
  • Report on project progress via monthly status reports

Ideally, you hold a relevant university degree – preferably a M.Sc. in Engineering, Pharmacy or the like. A PhD is preferred, but not a requirement.

The successful applicant will already have a proven record of accomplishment in transferring drug substance manufacturing processes from development to commercial with regard to pre-launch and post PPQ activities. The following qualifications are appreciated:

  • A minimum of 10 years of experience within the field of biological drug substance manufacturing and downstream purification from the pharmaceutical industry
  • Experience with pre-launch and post PPQ activities such as upscaling/tech transfer of manufacturing processes/continuous process verification
  • Experience with late stage development and pilot production experience with project management
  • Experience with outsourcing of development and GMP drug substance manufacturing activities
  • Experience within regulatory and QA requirements with EMA and FDA regulations for intermediates/drug substances to be manufactured for market supply

You are proficient in English and Danish at a professional level, both written and spoken, and you master MS Office.

You are a person who has a personal commitment to delivering results. You are analytical and science-driven, and you identify and resolve problems in a timely manner. You are a flexible, adaptable, and robust person with a hands-on attitude. You are pragmatic with an open and communicative approach and with the ability to develop effective working relationships with employees at all levels. You are able to handle and deliver on routine jobs when necessary, while at the same time having the ability to move projects forward.

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: 20 – 30 days/year 

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

For more details about the job or the company, please contact Partner Life Science Jørn Duhn, Unique Human Capital on M +45 21 75 19 25. All applications must be submitted in English and are treated confidentially.

Unique Human Capital A/S
T +45 7020 6700
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cvr: 31502705
Stamholmen 157, 1. tv
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
Søren Frichs Vej 42R
8230 Aabyhøj
Unique Human Capital Poland Sp. z o.o.
+48 531 785 064
ul. Gie³dowa 4a, lokal 191
01-211 Warszawa