Senior Scientist - Bioanalysis

Your Role:

• EMD Serono in Billerica, MA is hiring a Senior Scientist. The New Biological Entities Drug Metabolism and Pharmacokinetics (NBE DMPK) Senior Scientist role is a scientific and operational role in Research and Development (R&D). Our company is committed to bringing transformational medicines to patients, and you will collaborate in a matrixed environment with other passionate functional experts to deliver novel biotherapeutics.
• Responsibilities:
• Development and fit-for-purpose validation of bioanalytical methods to be applied in sample analysis for molecules in discovery and development phases. Your work will support the characterization of multiple molecules and modalities, including multi-specific NBEs, antibody-drug conjugates (ADCs), antibody oligonucleotide conjugates (AOCs), and other biologics, from molecule design through preclinical and clinical phases, thus fulfilling internal and regulatory requirements. Representative technologies could include innovative immunochemical and ligand binding techniques such as ELISA, MSD-ECLA, Gyrolab, and others.
• Development of complex experimental study designs, interpretation of analytical data, good knowledge of immunogenicity, and technical report writing according to current company and industry standards.
• Ensuring timely delivery, with appropriate quality, of ligand-binding assay (LBA) bioanalytical deliverables (method development, qualification, and its application to in-vivo animal studies), and if needed, responsible for conducting/supervising critical reagent characterization.
• Recommending data decisions to the lab manager by providing solid results, findings and technical solutions to project issues/problems.
• Conducting scientific literature research to address complex technical issues and evaluate and implement potential new analytical strategies and technologies as needed.
• Monitoring bioanalytical studies at contract research organizations (CROs).
• Who You Are:
• Minimum Qualifications:
• PhD in Biochemistry, Biology, Chemistry, or other Science field, with 2+ years post PhD experience in PK, bioanalytics, immunogenicity, and/or other drug discovery/development experience
• 2+ years of experience with biological molecules (NBEs, ADCs, AOCs, or other novel modalities)
• Preferred Qualifications:
• Excellent experimental design and troubleshooting skills, and excellent data analysis & data mining skills