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CMC Project Manager

Join the Development team in a leading and fast-growing biotech company on its way to becoming a fully integrated pharmaceutical company.

Ascendis Pharma is expanding its CMC resources to support the PAI-process for a late-stage biologic project as well as mature one of the peptide development projects. Ascendis is therefore looking to hire a passionate Project Manager within downstream processing to provide effective support of and coordination with Ascendis’ Phase 2 and Phase 3 projects.

As CMC Project Manager at Ascendis Pharma, you will be responsible for supporting and outsourcing process development, process optimization and transfer activities at Contract Manufacturing Organizations (CMOs). As Project Manager within the CMC Biologics Development group, you will work to ensure continuous good relations and alignment with Ascendis’ CMOs worldwide and stay updated with insights into their manufacturing processes. You will be planning and coordinating activities at the CMOs in collaboration with your colleagues and the project responsible person at the CMO.  Your day-to-day responsibilities will vary ranging from detailed process discussions, reviewing MBRs and defining control strategies to overall planning. You will report to the Vice President for Biologics Development and you will collaborate with other CMC departments within Ascendis. You will join a very dedicated and experienced team in a strong science-based company.

The main responsibilities are:

  • Scientific lead for the conjugation chemistry and purification of API for a project in clinical phase 2 development
  • Coordination and oversight of manufacturing process transfer from development laboratories or across sites
  • Oversight of manufacturing activities by CMOs
  • Together with other members of the CMC team, ensure that the CMC part of the project is conducted optimally with respect to quality, timelines and budget
  • Participate in outlining CMC agreements and work orders for specific projects together with the legal staff
  • Involved in writing regulatory documentation for the CMC part of INDs/IMPDs
  • Support inter-departmental communication and ensure effective handoffs to execute on important project milestones

For the project in the final stage of process validation:

  • Participate in the team responsible for completing technical and scientific tasks in preparation for PAI
  • Oversight of CMOs in execution and reporting of experimental work

Success criteria in this role will be to establish robust manufacturing procedures for the downstream process for Ascendis’ projects and to support process development activities at the CMOs. You will contribute actively within the CMC project teams regarding manufacturing challenges and establish close and high-standard collaborations with the CMOs that Ascendis works with.

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 demand.

The successful applicant will already have a proven record of accomplishments in delivering API manufactured according to GMP within given deadline and budget. The following qualifications are preferred:

  • A minimum of 3-5 years of experience within the field of CMC in the pharmaceutical industry
  • Solid scientific background in downstream processing (e.g. chromatography, filtration technologies)
  • Experience with manufacture or up-scaling of manufacturing processes for biologic APIs
  • Experience within regulatory and QA requirements for drug substances
  • Experience with late stage clinical development projects is an advantage
  • Experience with outsourcing of development and GMP manufacturing activities is an advantage
  • A natural interest in handling and evaluating data

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

You have a personal commitment to deliver 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. You pay attention to the details simultaneously maintaining focus on the overall picture. You have a flair for project management and enjoy working on a high energy level. You can work independently, and you have very good interpersonal skills.

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’ strategy and work together with highly skilled and experienced colleagues to advance Ascendis’ exciting product pipeline.

Travelling: 10- 20 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 CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
Vi er over 200 mennesker, der arbejder med viden, kreativitet og teknologi
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