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Stability Coordinator Job in Denmark
Ascendis Pharma , Denmark

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Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Requires Traveling
No
Career Level
Telecommute
No
Qualification
Bachelor's Degree
Total Vacancies
1 Job
Posted on
Apr 20, 2021
Last Date
Jul 20, 2021
Location(s)

Job Description

Ascendis Pharma a visionary and ambitious company, offers you the opportunity to become involved in the development of best-in-class therapeutics for rare diseases addressing unmet medical needs and making a meaningful difference in patients’ lives.

Ascendis Pharma is expanding its CMC resources to support and mature their development projects and are now looking to hire a passionate administrative person with a structural mindset to help coordination and administration of drug product stability studies. As Stability Coordinator at Ascendis Pharma you will be responsible for supporting the stability SMEs by the administrative part of the stability studies.

You will join the CMC Pharmaceutical Development I team and be part of the highly experienced and dedicated team consisting of 7 scientists. Among others the team has close relationship with our colleagues in CMC development, analytical development, product supply and quality assurance. You will report directly to the Director, CMC Pharmaceutical Development I.

As Stability Coordinator you will:

  • In collaboration with stability SME support initiation of stability studies with respective CMOs. This includes agreements, budgeting, administrative review of stability protocols and coordination within Ascendis Pharma to assure timely initiation.
  • Be responsible for maintaining overview of stability studies and assuring timely reporting, transfer of data and/or data review for further processing and shipment of samples between CMOs.
  • Be responsible for assuring that studies, data and related documentation (e.g. CMO created deviations, change controls, protocols, reports) are archived in Ascendis Quality and document system.
  • Together with the SME maintain the overview and assure that data from the stability studies are in place in due time for critical deliveries such as submissions to health authorities.

Success criteria in this role will be to establish an at all times complete overview of all GMP stability studies initiated and timely assure data are available for further processing, with an eye on critical deliveries. You will contribute actively within the CMC project teams regarding stability studies. Additionally, you will be an active player in establishing a close and high-standard collaboration with the CMOs that Ascendis Pharma works with and will be a value-adding resource to them.

Your qualifications are at least 2 years of experience in the pharmaceutical industry. You enjoy working with administrative tasks, are service minded and expert in keeping a structured household. It will be an advantage that you are familiar with stability studies and are able to keep a great overview. Moreover, a previous experience in working with external collaborators such as CMOs/CLOs as well as an insight into the CMC development process will be an advantage, but not a pre-requisite. You are proficient in English at a professional level, both written and spoken, and you master MS Office.

You have a Technician, Pharmacist Technician or similar education, or you have worked within the pharmaceutical industry for several years.

You are a person who thrive in an environment with focus on collaboration and communication. You are highly motivated and work independently and understand the needs of your closest colleagues to ease their daily work. An ability to communicate with other development staff and external collaborators in a fast-paced environment is crucial. You pay attention to the detail simultaneously maintaining focus on the overall picture and you have a structured approach. Finally, you must have 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 with highly skilled and experienced colleagues to advance Ascendis’ exciting product pipeline.

Travelling: 5-10 days per year.

Domicile: 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 Director CMC Pharmaceutical Development I, Anja R. H. Skands on 24 44 68 73. All applications must be in English and are treated confidentially.


Job Specification

Ascendis Pharma

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