Senior Scientist - Biologics & Vaccine BioAnalytics Job

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Merck & Co. Biologics and Vaccines Bioanalytics (BVB) supports PK, immunogenicity and biomarker assay development, validation and testing for development stages (preclinical and clinical) and life-cycle management of Biologics and Vaccines programs. We are seeking a highly talented and motivated individual with a strong background in protein science or immunology for quantification of biologics molecules and evaluation of anti-drug antibodies in biological matrices, to support PK and immunogenicity assessments for pre-clinical and clinical studies.

- Develop, validate and implement ADA or PK immunoassays. - Independently apply basic scientific principles, perform literature searches, attend scientific meetings, and keep abreast of literature in the biotherapeutic bioanalysis field. - Write SOPs, validation reports, and bioanalytical reports - Provide update of project status at periodic project review meetings. - Comply with GxP regulations (GLP and GCP); maintain proper records in accordance with SOPs and policies. - Participate in cross departmental project teams when assigned.

**Education:** - A PhD in Biochemistry / immunology / Pharmaceutical Sciences or a related field **Required:** - Knowledge and experience in biochemical or immunological assays - Capable of working independently under moderate supervision and possess good communication skills (written and verbal). - Knowledge and experience developing immunoassays, and demonstrated immunoassays trouble shooting skills. - Good organizational and time management skills in order to handle multiple projects in parallel. - Ability to critically evaluate and interpret data. **Preferred:** - Knowledge and experience working in a GLP/GCP environment - Knowledge and experience with bioanalytical assays, LC/MS - A PhD in Biochemistry/immunology/Pharmaceutical Sciences or a related field - Knowledge and experience in biochemical or immunological assays - Capable of working independently under moderate supervision and possess good communication skills (written and verbal). - Knowledge and experience developing immunoassays, and demonstrated immunoassays trouble shooting skills. - Good organizational and time management skills in order to handle multiple projects in parallel. - Ability to critically evaluate and interpret data. - Knowledge and experience working in a GLP/GCP environment - Knowledge and experience with bioanalytical assays, LC/MS