Bioanalytical Scientist

at  Ascendis Pharma

Are you passionate about bioanalysis and data interpretation? Do you want to work in a dynamic, international environment? If so, now is your chance to join Ascendis Pharma as our new Bioanalytical Research Scientist in Department of Clincial Pharmacology & Bioanalysis.
Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States. Guided by our core values of patients, science, and passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs, focused on making a meaningful difference in patients’ lives.
We are seeking a passionate Bioanalytical Research Scientist to join our growing team. As our new colleague, you will provide input to bioanalytical assay strategies (PK and immunogenicity), assay method development, and bioanalytical operations. Your tasks will include outsourcing bioanalysis work to CROs to develop and validate assays, and monitor study conduct. Depending on your experience, background, and interest, you will also take part in non-compartmental PK/PD analysis, interpretation of data, and authoring of regulatory documents.
We are looking for an engaged, detail-oriented, and result-focused colleague who is passionate about bioanalysis and drug development. We offer you room to grow and the freedom to take responsibility and make a difference for patients every day. As a member of our global team, you will work closely with highly skilled and passionate colleagues across the world to advance our exciting product pipeline.

In the role, you will

• Provide input to design, conduct, coordination, outsourcing, and oversight of PK and immunogenicity bioanalyses. The outsourced bioanalysis- and immunogenicity assays may involve methods for both large and small molecules and methodologies including ligand binding assays & LC-MS/MS
• Participate in the analysis and interpretation of data from nonclinical and clinical studies in various therapeutic areas in our growing pipeline
• Work in close collaboration with colleagues within the department as well as research, nonclinical, clinical, biometrics, and vendors
• Communicate to relevant stakeholders, including project teams
• Give input to bioanalysis sections of non-clinical and clinical protocols and reports, regulatory documents, scientific manuscripts, and external presentations

Your professional qualifications

You hold a relevant MSc degree in Chemistry, Biotechnology, Pharmacy, or other related Life Science area with experience within some of the following areas:

• Bioanalysis of complex molecules and design of suitable analytical strategies
• Immunoassays, LC-MS/MS, or cell-based assays
• Small and large molecule bioanalytical assay development and validation in accordance to applicable regulatory guidelines
• Outsourcing analytical methods in a GLP/GCP environment including platform/vendor selection and contracting
• Providing input to e.g., non-clinical study plans, clinical protocols, bioanalytical study plans, lab manuals, CSRs, and regulatory documents
• Understanding of drug discovery and clinical drug development in early and/or late stage drug development and familiarity with regulatory approval process
• Ability to perform and interpret non-compartmental & compartmental PK (Phoenix)
• Proficient in English at a professional level, both written and spoken

As a person, we expect you to

• Possess a positive can-do attitude and good collaboration skills to establish professional engaging relations internally and externally
• Possess strong communication and stakeholder management skills being able to provide clear recommendations to study teams, project teams, and other stakeholders
• Be proactive and self-motivated with a strong drive, able to manage multiple objectives in parallel, and comfortable to work in an informal, dynamic environment and adapt to changing priorities

Travel: 10 days per year.
Office location: Ascendis Pharma resides in a modern and bright office facility in Tuborg Havn in Hellerup with a view to the harbor, the canals, and the sea.
Apply now. Applications will be evaluated when received, so please apply as soon as possible. Applications must be submitted in English and are treated confidentially.
For more details about the position or the company, please contact Head of Clinical Pharmacology & Bioanalysis Britta Bysted, +45 6161 5084, or Director Eva Christoffersen, +45 2018 1971, or visit our website www.ascendispharma.co

• Provide input to design, conduct, coordination, outsourcing, and oversight of PK and immunogenicity bioanalyses. The outsourced bioanalysis- and immunogenicity assays may involve methods for both large and small molecules and methodologies including ligand binding assays & LC-MS/MS
• Participate in the analysis and interpretation of data from nonclinical and clinical studies in various therapeutic areas in our growing pipeline
• Work in close collaboration with colleagues within the department as well as research, nonclinical, clinical, biometrics, and vendors
• Communicate to relevant stakeholders, including project teams
• Give input to bioanalysis sections of non-clinical and clinical protocols and reports, regulatory documents, scientific manuscripts, and external presentation