MSD Malaysia
Associate Principal Scientist, Vaccines Clinical Assays
MSD Malaysia, Gwynedd Valley, Pennsylvania, United States
* 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.* 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* 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**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance #J-18808-Ljbffr
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.* 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* 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**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance #J-18808-Ljbffr