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Director CMC

Director CMC in a fast growing biotech company

As Director CMC at Ascendis Pharma the main success criteria is to create a good understanding of deliverables to the project(s) from the CMC project team members and to be able to establish a close and high-standard cooperation with the CMOs used by Ascendis Pharma and to become a value-adding resource to them.

 You report directly to the VP, CMC Pharmaceutical & Device Development and will be part of a very dedicated and experienced team.

Your main responsibilites are:

  • For the Phase 3 project TransCon hGH, the Director CMC will, together with the Drug Product responsible Director, be responsible for outlining pre-PPQ and PPQ activities at the CMOs manufacturing GMP Drug Product. You will use your experience within the fields of late-stage product development and manufacturing development to guide and drive the process for having PPQ manufacturing performed in a timely manner
  • Following the project when the project is moved from Product Development into Product Supply, responsible for the market supply
  • Defining pre-PPQ activities, and leading PPQ manufacturing
  • Ensure the PPQ project is conducted optimally with respect to quality, timeliness, and budget
  • As daily point of contact, you will be responsible for project management/coordination of development and manufacturing activities between CMO(s) and Ascendis Pharma during the PPQ phase and later on in the commercial phase as part of Product Supply
  • Responsible for outlining CMC agreements and work orders together with Product Supply and the legal staff
  • Involved in writing regulatory documentation for the CMC part of an NDA/MAA
  • Support inter-departmental communication and ensure effective handoffs to execute on important project milestones
  • Report on project progress via line management and project review meetings

Ideally, you hold a Master’s Degree in Science, Engineering or Pharmacy, or the like.

The successful applicant will have a proven record of accomplishment in transferring the manufacturing part of a development project to market supply with regard to PPQ activities manufactured according to GMP. The following qualifications are appreciated:

  • A minimum of 5 years of experience within the field of manufacturing from the pharmaceutical industry. It would be an advantage, if you have experience with transfer & upscaling manufacturing processes, and have been involved in pre-PPQ and PPQ activities.
  • Experience with at least one CMC project during late stage development.
  • Experience with project management of multi-functional CMC project teams.
  • Experience with outsourcing of development and GMP manufacturing activities.
  • Experience within regulatory and QA requirements with EMA and FDA regulations for drug products to be manufactured for market supply.

You are proficient in English 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 of the harbor, 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 or Senior Consultant, Jannie Jensen, Unique Human Capital, on M: +45 29 72 78 86. All applications must be submitted in English and are treated confidentiall.

 

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 long-acting 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.

For further information, please see ascendispharma.com

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Unique Human Capital A/S
cvr: 31502705

Stamholmen 151
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
T +45 7020 6700
Marselis Tværvej 4
8000 Aarhus C
Unique Human Capital Poland Sp. z o.o.
ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
Poland
T + 48 22 291 32 20