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.
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.
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
Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as 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.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
BACK TO TOP
CAIA Career Center is Just One of the Benefits.
Discover what else CAIA has to offer!
The job you are trying to reach from was originally posted at CAIA Career Center.