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Director CMC, Drug Substance

You will work amongst some of the best CMC experts 

As Director CMC at Ascendis Pharma you are expected to create a good understanding of CMC deliverables in the project teams and to establish a close and high-standard cooperation with the CMOs used by Ascendis Pharma.

The Director CMC reports to the Senior Director for Late Stage Biologics development. Ascendis has very strong and technically experienced CMC departments and in this position, you will be amongst some of the best experts within product development.

The main responsibilities are:

  • Scientific lead for the development and manufacturing of drug substance (conjugation chemistry and purification) in two new development projects
  • Ensure that the CMC activities are conducted optimally with respect to quality, timelines and budget
  • Secure knowledge transfer across projects
  • Manage outsourced activities at CMOs
  • Support inter-departmental communication and ensure effective handoffs to execute on important project milestones
  • Outline CMC agreements together with the legal staff
  • Write relevant sections of regulatory documentation for the CMC part of INDs/IMPDs
  • Communicate project progress to senior management

Ideally, you hold a relevant university degree – preferably a Master of Science in Biology, Chemistry, 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 delivering APIs manufactured according to GMP to deadline and on budget. The following qualifications are preferred:

  • A minimum of 5 years of experience within the field of CMC from the pharmaceutical industry, including up-scaling of manufacturing processes for biologic APIs
  • Solid scientific background in downstream processing and process development (e.g., chromatography, filtration technologies)
  • Experience with at least one CMC project conducted through more than one clinical development phase. Experience with phase II/III is an advantage
  • Experience with project management of multi-functional project teams
  • Experience with outsourcing of development and GMP manufacturing activities
  • Experience within regulatory and QA requirements for drug substances to be used in clinical phases

You are proficient in English and Danish on a professional level, both written and spoken.

You have 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 and have the routine to work independently, while at the same time having the ability to move projects forward.

Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial, science driven 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 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 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 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.

Read more at www.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