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(Senior) Scientist CMC Analytical Development

Join the CMC Analytical 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 within their peptide development projects and are now looking to hire a passionate scientist with analytical development expertise to provide effective analytical support to Ascendis’ phase 2 and phase 3 projects.

You will be responsible for supporting analytical method development activities at Contract Manufacturing Organizations (CMOs) and Contract Laboratory Organizations (CLOs), including method transfer and validation, release analysis, as well as stability testing for Starting Materials, Intermediates, APIs and Drug Products. You will join the CMC Analytical Development (SMOL & Peptides) team, which consists of highly experienced and dedicated colleagues.

With direct report to the Director, CMC Analytical Development (SMOL & Peptides).

Your main tasks are:

  • Implement/develop and validate product-specific analytical methods at CMOs/CLOs
  • Support the analytical team at CMOs/CLOs
  • Discuss and monitor execution of the analytical control strategies
  • Support planning of stability studies, as well as execute stability data trending, and evaluation
  • Support characterization activities e.g. identification of (new) impurities
  • Write, review, and approve analytical protocols and reports
  • Participate in setting specifications and justifying the acceptance criteria for starting materials, intermediates, in-process controls (IPC), drug substances and drug products
  • Write regulatory documentation for the CMC part of INDs/IMPDs, and eventually for the registration file

Your qualifications are several years of documented practical experience from the pharmaceutical industry within development of chromatographic analyses in GMP environment (e.g. HPLC/UHPLC, LC-MS, SEC) for small molecules and/or synthetic peptides, either from an Analytical Development or a QC laboratory. Knowledge of other analytical techniques, as well as insight into the CMC development process, is preferable. Finally, you are proficient in English at a professional level, both written and spoken.

You hold a Master’s Degree in Chemistry, Engineering, Pharmacy or similar. A PhD is preferred, but not a demand.

You are a person who thrives in an environment with a focus on collaboration and communication. You are highly motivated, work independently and enjoy being professionally challenged. Strong interpersonal skills are necessary, as you will serve as a major contributor and trusted member of the project development teams. A proven ability to communicate with other development staff and external collaborators in a fast-paced environment is crucial. You pay attention to detail, and simultaneously maintain focus on the overall picture. 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’ strategy and work with highly skilled and experienced colleagues in order to advance Ascendis’ exciting product pipeline.

Travelling: 10-15 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 Senior 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
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