Job Description
We aspire to be the premier research-intensive biopharmaceutical company. At our company, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Join us in our mission to make a difference.
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 the 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.
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
Required
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.
Required Skills:
Automated Cell Culture, Bioanalytical Method Development, Bioreactor Operation, Data Science, Financial Research, Interpersonal Relationships, In Vivo Studies, Membrane Filtration Systems, Product Development,…