Are you passionate about assay and method development, and do you thrive in a high-paced environment where you can influence how Y-mAbs work?

As Principal Scientist, Assay Development at Y-mAbs, you will play a key role in assay development, analytical method development, and validation activities for biochemical assays. This responsibility involves optimization for non-clinical and clinical assays and therapeutic protein drugs.

With direct report to Chief Scientific Officer.

Your main tasks include, but are not limited to:

• Establish overall development plans for assays of upcoming assays
• Contracting with bioanalytical CROs (PK, ADA, DFA, and biomarker), including oversight, troubleshooting, and ensuring the right compound quality and documentation are available at CROs
• Collaborate on the development and validation/qualification of preclinical assays (PK, ADA, and dose-formulation (DFA) assays), non-GLP, and GLP quality
• Input to sampling time points in preclinical studies and PK calculation of PK data (non-GLP)
• Development and validation of clinical PK, ADA, and biomarker assays (GLP/GCLP quality)

Your qualifications are more than 5 years of work experience in the biotechnology or pharmaceutical industry in cell therapy or Biologics. You have a solid scientific background in cellular biology and cell culture systems. You possess expertise in developing cell-based assays using analytical methods such as IHC, PK, ADA, etc. You understand regulatory requirements for method validation under GMP, have experience with defining specifications, and can interpret data. You are preferably fluent in Danish, written as spoken.

You have a degree-level qualification in Chemistry, Biochemistry, Pharmacology, Biology, or equivalent.

You are a dedicated, result-oriented team player who enjoys working in an innovative and passionate environment. You are proactive and self-driven, excellent at multi-tasking, have an entrepreneurial work approach, and can navigate a matrix organization across different departments and functions.

Y-mAbs offers an exciting career opportunity in a young, growing international company that fosters an open, trusting atmosphere. Y-mAbs provides significant professional and personal growth opportunities for its employees and is committed to helping employees balance work life and personal time.

Traveling: Approx. 10 days per year.

Domicile: In commuting distance of the office in Hørsholm.

For more details about the job or the company, please contact Research Consultant Emma Dahl, Unique Human Capital on M: +45 51 43 43 17 or by email: ejd@uhc.dk. All applications must be in English and are treated confidentially.