Associate Director, Bioanalytics - Global Preclinical Development

Merck•Rahway, NJ

1d•$142,400 - $224,100•Onsite

About The Position

The Associate Director, Bioanalytics leads the Rahway Bioanalytical Laboratory within Global Preclinical Development, providing scientific, operational, regulatory, and people leadership for bioanalytical activities supporting research, business, preclinical, and clinical development programs for veterinary pharmaceuticals. The role is accountable for timely delivery of high-quality, scientifically sound, and regulatory-compliant bioanalytical data and documentation while developing the Rahway Bioanalytics team and collaborating with internal and external partners.

Requirements

Ph.D. in analytical chemistry, bioanalytical chemistry, pharmaceutical sciences, biochemistry, or a related scientific discipline and at least 6 years of relevant industry experience; or a Master's degree in a relevant scientific discipline and at least 10 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 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.

Nice To Haves

Experience supporting regulatory submissions for veterinary or human pharmaceuticals and interacting with regulatory, quality, or compliance organizations.
Experience managing bioanalytical activities performed by CROs 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.

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 improve 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, particularly mass spectrometry.
Ensure scientific quality, data integrity, documentation, and compliance with GLP, internal procedures, and regulatory requirements.
Review bioanalytical data, methods, protocols, and reports for 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.