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Merck · 1 day ago

Associate Principal Scientist, Vaccines Clinical Assays

Ambler, PA

Full-time

Hybrid

Senior Level, Lead/Staff

$140K/yr - $220K/yr

4+ years exp

Merck is a global health care leader focused on creating a healthier future. They are seeking a highly motivated Associate Principal Scientist to join the Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalysis (PDMB) to modernize Bioanalytics for vaccines by developing and validating clinical assays while ensuring compliance with regulatory standards.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

H1B Sponsored

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

Qualification

Bioanalytical AssaysRegulatory SubmissionAssay DevelopmentImmunoassaysAutomated Liquid HandlingDesign of ExperimentsCell-Based AssaysTeam LeadershipCommunication SkillsMentorship

Required

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

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

Automated Liquid Handling Systems

Bioanalytical Assays

Bioanalytical Method Development

Bioanalytical Techniques

Cell-Based Assays

Clinical Testing

Immunoassays

Method Development

Regulatory Filings

Regulatory Management