Associate Principal Scientist, Vaccines Clinical Assays Full-time

Associate Principal Scientist

Our Company 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.

We are seeking a highly motivated Associate Principal Scientist to join the Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalysis (PDMB) in the area of Regulated Bioanalytical Early Development Vaccines. Our team is modernizing Bioanalytics with regulated end-to-end automation; data tracking, analysis, and visualization; and automated liquid handling. The primary role of the successful candidate will be to design, develop, qualify/validate, tech transfer, and/or troubleshoot modernized clinical assays for our vaccines portfolio. Importantly, the successful candidate will have a proven track record for developing assays capable of meeting regulatory expectations. The candidate should be current on state-of-the art technologies and champion the evaluation of new technologies and optimization of processes. Providing leadership and mentorship to junior staff, building relationships with stakeholders, and providing expert technical representation on multidisciplinary teams will be expected.

Key Responsibilities:

• Provide scientific input to design of immunoassays such as ligand binding, molecular and/or cell-based assays supporting investigational vaccines.
• Work with a team to lead method development, qualification/validation, assay bridging, troubleshooting and/or assay format.
• Assess and implement new technologies.
• Serve as an internal subject matter expert on developed assays, providing technical support as needed to internal and external laboratories working to implement assays.
• Ensure assays are developed and executed in compliance with applicable Guidance and Regulations. Contribute to assay protocol, qualification/validation report, and/or study report preparation. Address QA findings and observations.
• Contribute to regulatory filings pertaining to assay details.
• Communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, write technical reports, and participate on cross-functional teams.

Qualifications:

Education:

• Bachelor's (with 12+ years), Master's (with 8+ years) or Ph.D. (with 4+ years) in Biological Sciences such as Virology, Immunology, Cell biology or related field and relevant experience in the development and qualification/validation of assays in a regulated environment

Required Experience and Skills:

• Experience as a subject matter expert in the field of regulated analytical and/or bioanalytical development and validation of antigen-specific antibody binding assays (ELISA, multiplex at our Company, or Luminex)
• Knowledge and expertise in development, Design of Experiments (DoE), qualification/validation, and regulatory submission for regulated vaccine analytical or bioanalytical assays
• Ability to independently analyze and interpret experimental data and to present and discuss results within a multi-disciplinary team environment
• Team player with excellent oral and written communication skills as evidenced by scientific publications and presentations at scientific meetings

Preferred Experience and Skills:

• Additional experience with molecular and/or functional antibody assays (cell-based virus neutralization, OPK/MOPA)
• Familiarity with liquid handlers and other automation platforms for sample preparation and assay process
• Demonstrated supervision and mentorship of small teams

Required Skills: Automated Liquid Handling Systems, Bioanalytical Assays, Bioanalytical Method Development, Bioanalytical Techniques, Cell-Based Assays, Clinical Testing, Immunoassays, Method Development, Regulatory Filings, Regulatory Management, Vaccine Development, Virology

Preferred Skills:

The salary range for this role is $139,600.00 – $219,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.