Merck & Co.-posted about 1 year ago
Full-time • Senior
Onsite
1,001-5,000 employees
Chemical Manufacturing

The Associate Director for the Liquid Handlers team within the Regulated Bioanalytics Department will lead the design, transfer, and development of preclinical and clinical assays for vaccine pipelines using robotic systems in a regulated environment. This role involves overseeing automation transfers, qualification, validation, and troubleshooting while ensuring compliance with applicable regulations. The successful candidate will also provide leadership and mentorship to junior staff and collaborate with multidisciplinary teams to drive innovation in bioanalytical testing.

  • Design and oversee operations of robotic systems to validate, optimize, and execute new vaccine program clinical assays on various automation platforms in a regulated environment.
  • Inform method development, qualification/validation, troubleshooting and/or assay format selection based on risk assessment and fit-for-purpose considerations.
  • 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 (e.g., GxP).
  • Contribute to assay protocol and qualification/validation report preparation; address QA findings and observations.
  • Contribute to regulatory filings pertaining to assay details as needed.
  • Communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to write technical reports, and to participate on cross-functional teams.
  • Adhere to basic safety procedures in a BSL2 laboratory and compliance to regulations.
  • Provide scientific oversight for robotic platforms assays being implemented internally and externally, including review of trending data and technical reports.
  • BA/BS with 10 years of experience, MA/MS with 6 years of experience, or PhD with 4 years in Engineering, Automated Sciences, Computer Science, Biology, Chemistry or equivalent.
  • Experience with laboratory automation schedulers such as Cellario, Green Button Go, or Momentum.
  • Familiarity with liquid handlers and other automation platforms for sample preparation and assay process.
  • Experience with various assays formats, including immunology assays such as ELISA, AlphaLISA, multiplexed ligand binding assays (LBA), or in vitro primary immune cell functional assays such as ELISpot or multi-color flow cytometry.
  • Ability to lead, mentor, and inspire engineers and scientists at various levels.
  • Well-developed decision-making skills that think broadly across development programs.
  • Familiarity with Regulated Bioanalysis and Good Laboratory Practice (GLP).
  • Ability to independently analyze and interpret experimental data and to present and discuss results within a multi-disciplinary team environment.
  • Experience in Agency inspections/audits.
  • Proficiency to utilize statistical software for design of experiments.
  • Current knowledge of state-of-the-art technologies in bioanalytical testing.
  • Experience with regulatory submissions.
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