Analytical Scientist/ Pr. Manager

Ascendis Pharma

Nov 2nd, 2022

Join the Analytical Development team in a leading and fast-growing biotech company
Ascendis Pharma is focused on building a leading rare disease company that provides meaningful improvements in patients’ life by developing best-in-class therapeutics that address unmet medical needs by applying our TransCon technology platform.
CMC Analytical Development team is expanding its CMC resources to support a new peptide project in early development. We are looking for a science driven analytical scientist with pharmaceutical experience within development of chromatographic methods for small molecules and/or synthetic peptides (e.g. UPLC/HPLC, GC, LC-MS, IC, SEC).
Scientist/Project Manager in Analytical Development will be responsible for supporting and overseeing execution of analytical method development and validation activities at Contract Manufacturing Organizations (CMOs) and Contract Laboratory Organizations (CLOs). Furthermore, in collaboration with project team colleagues the analytical scientists will participate in defining activities necessary to support the analytical control strategy for Ascendis small molecule and peptide development projects.
You will be part of the team consisting of 11 experienced and dedicated analytical scientists/project managers, who collaborate on day-to-day basis with Chemical Development and Pharmaceutical Development teams. The Analytical Development (SMOL & Peptides) team has also close relationship with our colleagues in Heidelberg, who support our development activities for the manufacturing processes and analytical methods.
The main areas of responsibility for the analytical development group are:

  • Implementation/development and validation of product-specific analytical methods at CMOs/CLOs
  • Transfer of analytical methods between CMOs/CLOs
  • Supporting analytical team at CMOs/CLOs and at the Ascendis Pharma Heidelberg facility with analytical development and troubleshooting
  • Release analysis and stability testing for Starting Materials, Intermediates, and Active Pharmaceutical Ingredients (APIs) at CMOs/CLOs
  • Stability data trending and evaluation
  • Writing regulatory documentation for the CMC part of INDs/IMPDs, and eventually for the registration dossier
  • Writing, reviewing and approving analytical protocols and reports
  • Supporting characterization activities e.g. identification of (new) impurities
  • Participating in setting specifications and justifying the acceptance criteria for starting materials, intermediates, in-process controls (IPC) and drug substances

Your areas of responsibility:will be dependent on your qualification and experience.
Success criteria in this role will be to establish reliable and robust analytical methods at the CMOs to support clinical supply for our development programs. You will contribute actively within the CMC project teams regarding analytical challenges as well as discuss and implement the control strategy from an analytical point of view. Additionally, you will be an active player in establishing a close and high-standard collaboration with the CMOs/CLOs that Ascendis Pharma works with and will be a value-adding resource to them.
Your qualifications:at least 3 years of documented practical experience from the pharmaceutical industry within analytical development for small molecules and/or synthetic peptides, either from an Analytical Development or a QC laboratory. A hands-on GMP knowledge as well as insight into the CMC development process is preferable. Moreover, a previous experience in working with external collaborators such as CMOs/CLOs will be an advantage.
Furthermore, you have a large interest in being involved in complex analytical chemistry. You are proficient in English at a professional level, both written and spoken.
You hold at least a Master’s Degree preferably in Chemistry, Engineering, Pharmacy or similar.
You are a person who thrive in an environment with 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 the detail simultaneously maintaining 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 Pharma’s strategy and work with highly skilled and experienced colleagues 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 Director CMC Analytical Development (SMOL & Peptides), Kate Wojtachnio-Zawada on 28 42 48 70.
All applications must be in English and are treated confidentially.

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