We are seeking a highly motivated Principal Scientist (same benefit band as Director at Merck) to join the Regulated Immunogenicity and Molecular group within the department of Preclinical Development-Bioanalytical (PCD-BA) to drive immunogenicity analytical strategy that incorporates well-designed assays to advance candidates through clinical development. Successful candidates should have extensive experience in development, optimization, qualification and/or validation of biologics neutralization antibody (NAb) assays. The candidate should also have in-depth quality and compliance knowledge that aligns with current immunogenicity regulatory guidances and regulations, with deep expertise applying these concepts while overseeing the end-to-end NAb assay strategy. Training and mentoring lab staff is also required in order to drive a consistent quality culture across the team. Candidates without all qualifications will be reviewed and could be successful based on past achievements and a desire for continued learning.

Reponsibilities include:

• Lead and mentor scientists up to Ph.D. level by providing technical direction and scientific feedback, and by encouraging ideas and experimentation.
• Scientific strategy and oversight of development, optimization/troubleshooting, qualification, and validation of biologics NAb assay. Review and approve notebooks, test methods, and reports.
• Author regulatory filings and respond to regulatory authority questions pertaining to NAb assay strategy and execution. The candidate will perform risk assessments, author reports, and interpret study data.
• Benchmarking current approaches/techniques to the industry standards.
• Design, pressure-test, and implement novel approaches, such as new technology, automation, and workflows hands-on on NAb assays. Publish paper with novel ideas, troubleshooting and imporvement of NAb assays.
• The candidate is expected to remain current in the field and maintain an external presence in the field of biologics immunogenicity.
• Represent PCD BA in early/late biologics development teams and Influence bioanalytical strategies together with stakeholders. Communicate results effectively to project teams and upper management.
• Represent Merck PCD BA in external working groups.

Qualifications:

• PhD in Biological Sciences such as Microbiology, Immunology, and Biochemistry, or related area with 8+ years, a MS degree with 10+ years, or BS degree with 14+ years of relevant experience

• Deep knowledge and expertise in development, validation, and troubleshooting of biological neutralization antibody (NAb) assays. Experience with multiple assay formats such as cell-based functional, cell-based binding or competitive ligand binding assay is preferred. 
• Deep understanding of in-depth quality and compliance knowledge that aligns with current procedures, guidance, and regulations and have deep expertise applying these concepts while overseeing the end-to-end bioanalytical phase of testing.
• Experience overseeing regulated bioanalysis under Good Laboratory Practice (GLP), or equivalent regulated laboratory processes
• Preferred to have track record in biological NAb assay for regulated application, and direct experience with regulatory submissions of bioanalytical assays and strategies
• A team player with excellent oral and written communication skills; ability to work independently and as a scientific mentor for development and validation of assays
• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.  Excels at working cross-functionally and gaining alignment of new ideas or strategies 
• Experience implementing new technology or automation platforms
• Record of peer-reviewed scientific publications

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