Senior Leader, Bioanalytics - Global Preclinical

MSD; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ seeks an Associate Director of Bioanalytics to lead the Rahway Bioanalytical Laboratory within Global Preclinical Development.

You will provide scientific and operational leadership for bioanalytical activities across research, preclinical, and clinical programs, ensuring timely, high-quality data and regulatory-compliant documentation. The role emphasizes team development, mass spectrometry-based analysis, method validation, data integrity, and CRO oversight,

Qualifications

• Ph.D. in analytical chemistry, bioanalytical chemistry, pharmaceutical sciences, biochemistry or related discipline with minimum six years of industry experience; or Master's with minimum ten years of industry experience.
• Demonstrated experience in bioanalytical method development, validation and biological sample analysis in regulated environments.
• Experience in GLP-regulated environments and strong data integrity/regulatory documentation knowledge.
• Proven track record leading scientists and laboratory teams, including coaching and development.
• Strong expertise in quantitative bioanalysis, especially mass spectrometry.
• Preferred experience supporting regulatory submissions for veterinary or human pharmaceuticals and CRO/external lab oversight.
• Experience with additional bioanalytical technologies such as immunoassays or ligand-binding assays.
• Knowledge of pharmacokinetics and/or drug metabolism.
• Experience implementing laboratory automation and regulated digital data workflows.
• Project-management experience.

Responsibilities

• Lead the Rahway Bioanalytical Laboratory with scientific and operational oversight.
• Drive automation, digital technologies, and data workflows to improve efficiency and compliance.
• Develop and mentor the BioAnalytics team through performance management.
• Oversee method development, qualification, validation and sample analysis with emphasis on mass spectrometry.
• Ensure data integrity, documentation, and regulatory compliance.
• Review data, methods, protocols, and reports for regulatory submissions.
• Provide scientific guidance and drive continuous improvement of technologies and processes.
• Partner cross-functionally to define bioanalytical strategies for development programs and regulatory interactions.
• Oversee external bioanalytical activities by CROs and other labs.
• Evaluate emerging scientific and regulatory developments to advance capabilities.

Skills

Automated Cell Culture

Bioanalytical Method Development

Bioreactor Operation

Data Science

Financial Research

Interpersonal Relationships

In Vivo Studies

Membrane Filtration Systems

Product Development

Results-Oriented

Stakeholder Communications

Technical Mentoring

Technical Transfer

Transcriptome Analysis

Trend Knowledge

Education

Ph.D. in analytical chemistry / bioanalytical chemistry / pharmaceutical sciences / biochemistry or related discipline

Master's degree in a relevant scientific discipline

Tools

Regulatory compliant data management

Job description

Merck & Co., Inc. in Rahway, NJ seeks an Associate Director of Bioanalytics to lead the Rahway Bioanalytical Laboratory within Global Preclinical Development.

You will provide scientific and operational leadership for bioanalytical activities across research, preclinical, and clinical programs, ensuring timely, high-quality data and regulatory-compliant documentation. The role emphasizes team development, mass spectrometry-based analysis, method validation, data integrity, and CRO oversight,