Principal Scientist - Bioanalytical Development & Vaccines Clinical Assays 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.

• Lead development or transfer of immunochemistry-based bioanalytical methods in Pharmacokinetic (PK), Toxicokinetic (TK), Immunogenicity and biomarker areas to support Merck biologics and vaccine programs. Responsible for troubleshooting of issues occurred during method development or in-study phase.
• Develop and implement new technologies including but not limited to immunoassays and LCMS assays for use in PK, TK and immunogenicity studies for novel biologics and vaccines.
• Serve as Principle Investigator for method validation to support pre-clinical/clinical sample analysis studies.
• Ensure GLP compliance.
• Prepare/review study protocols and assay validation reports.
• Address QA findings and observations.
• Interact with sample manager, bioanalyst, instrument scheduler, report writer, QC/QA, etc to track project progress and ensure on time delivery.

Qualifications

Education:

• PhD Degree in molecular biology, immunology, microbiology, pharmacology, biochemistry, cell biology or related discipline.

Required:

• A minimum of 8 years of experience in development, optimization, validation and execution of immunoassays for PK and immunogenicity assessment in pharmaceutical/biotechnology or CRO industry.
• Familiar with regulatory guidelines related to PK, immunogenicity assessment and vaccine clinical testing.
• Excellent written and verbal communication skills.
• Ability to openly share information and work in a team setting.

Preferred:

• Bioanalytical assay development including PK and immunogenicity
• Vaccine clinical testing
• Experience with MSD, Luminex, Singulex, GyroLabs or MRM-mass spectrometry are strongly preferred.
• Experience in cell culture, flow cytometry and cell-based assays is a plus.