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Merck

Makes medicines, vaccines and animal treatments

Associate Director - Bioanalytics, Global Preclinical Development

Regulatory & Quality (Life Sciences)Posted on Nov 9
Full-timeRahway, NJ, USA

About the Job

Requirements

  • A Ph.D. in analytical chemistry, bioanalytical chemistry, pharmaceutical sciences, biochemistry, or a related scientific discipline, with a minimum of six years of relevant industry experience; or a master's degree in a relevant scientific discipline, with a minimum of ten years of relevant industry experience.
  • Demonstrated experience in bioanalytical method development, validation, and biological sample analysis in a regulated pharmaceutical, animal health, or comparable environment.
  • Experience working in a GLP-regulated environment and a strong understanding of data integrity and regulatory documentation expectations.
  • Demonstrated experience leading scientists and/or laboratory teams, including scientific direction, prioritization, coaching, and development.
  • Strong scientific expertise in quantitative bioanalysis, particularly mass spectrometry.
  • Required skills include automated cell culture, bioanalytical method development, bioreactor operation, data science, financial research, in vivo studies, membrane filtration systems, product development, technical mentoring, technical transfer, transcriptome analysis, and trend knowledge.

Responsibilities

  • Lead the Rahway Bioanalytical Laboratory, including scientific and operational oversight, prioritization, resource planning, and delivery of project commitments.
  • Drive laboratory automation, digital technologies, and integrated data workflows to increase efficiency, data integrity, compliance, and scientific capabilities.
  • Lead and develop the Bioanalytics team through performance management, coaching, and capability building.
  • Oversee bioanalytical method development, qualification, validation, and sample analysis, with particular emphasis on mass spectrometry.
  • Ensure scientific quality, data integrity, documentation, and compliance with GLP, internal procedures, and regulatory requirements.
  • Review bioanalytical data, methods, protocols, and reports to ensure scientific rigor and suitability for regulatory submissions.
  • Provide scientific guidance, resolve complex bioanalytical issues, and drive continuous improvement of technologies, processes, and capabilities.
  • Partner across functions to define and execute bioanalytical strategies and provide expertise to development programs and regulatory interactions.
  • Oversee external bioanalytical activities performed by contract research organizations and other laboratories.
  • Evaluate emerging scientific, technological, and regulatory developments to advance laboratory capabilities.

Desired Qualifications

  • Experience supporting regulatory submissions for veterinary or human pharmaceuticals and interacting with regulatory, quality, or compliance organizations.
  • Experience managing bioanalytical activities performed by contract research organizations or external laboratories.
  • Experience with additional bioanalytical technologies, such as immunoassays or ligand-binding assays.
  • Knowledge of pharmacokinetics and/or drug metabolism.
  • Experience implementing laboratory automation, computerized laboratory systems, and regulated digital data workflows.
  • Project-management experience.

About the Company

Merck

Makes medicines, vaccines and animal treatments

Merck develops prescription medicines, vaccines and veterinary treatments for patients, health systems and animal owners worldwide. Its vaccine portfolio includes Gardasil 9, which helps prevent cancers and other diseases caused by several types of human papillomavirus. The company takes potential treatments through laboratory research and clinical trials, then manufactures and sells approved products to drug distributors, hospitals, physicians and governments. Its animal health division sells medicines and vaccines to veterinarians, farmers and pet owners, while selected drug partnerships also earn shared profits or royalties. Founded in 1891, Merck is headquartered in Rahway, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Rahway, NJ
Founded
1891

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