Associate Director, Bioanalytics - Global Preclinical Development
Merck
Summary
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.
Job description
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.
Qualifications
- Ph.D. in analytical chemistry, bioanalytical chemistry, pharmaceutical sciences, biochemistry or a related scientific discipline with a minimum of six (6) years of relevant industry experience; OR Master's degree in a relevant scientific discipline with a minimum of ten (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 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.
Preferred
- 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.
Requirements
- Ph.D. in analytical chemistry, bioanalytical chemistry, pharmaceutical sciences, biochemistry or related discipline with minimum 6 years relevant industry experience; OR Master's degree in relevant scientific discipline with minimum 10 years 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
Benefits
- Medical, Dental & Vision
- Retirement Benefits
- 401(k)
- Paid Holidays
- Vacation
- Compassionate & Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.