Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Responsible for defining/designing, conducting and/or technical support of residue chemistry, metabolism, and bioanalytical studies to support world-wide registrations of veterinary pharmaceuticals.
This position is part of Drug Safety and Metabolism, Global Preclinical Development, based in New Jersey.
- Steer preclinical development of pharma projects with regard to residue chemistry/metabolims/bioanalytical requirements. Ensure that any deviations from the anticipated product profile arising from residue chemistry/metabolism/bioanalytical properties are promptly identified, and suitable strategies to address relevant issues are provided.
- Support research projects by providing residue chemistry/metabolism/bioanalytical expertise and ensure that decisions within projects are made based on sound scientific assessments.
- Identify and provide strategies to meet critical objectives and issues for acceleration or termination of projects with respect to residue chemistry/metabolism/bioanalytical, as applicable.
- Steer defence of pharma products with regard to residue chemistry/metabolism/bioanalytical requirements.
- Establish and maintain contacts with external experts and CROs to provide required capacities and expertise. Serve as Study Monitor, or occasionally Study Director, for any out-sourced work. Specifically, plan studies with relevant CROs, supervise conduct of studies, and ensure compliance with study protocols. Ensure quality of investigator's work/work product.
- Ensure planned residue chemistry/metabolism/bioanalytical study program(s) meet current legal and regulatory requirements (GLP, EU & FDA).
- Ensure correct scientific analysis of data and validity of study and expert reports within the area of responsibility (residue chemistry/metabolism/bioanalytical).
- Ensure efficient use of resources by setting priorities (in agreement with line function & Project Manager).
- Ensure availability of regular reports concerning results, costs, budgets and provide updates (line function and Project Manager) routinely.
- Ensure an overall high quality of development work and residue chemistry/metabolism/bioanalytical support through routine literature searches, participation in scientific conferences, and contacts with relevant scientific opinion leaders.
- Sharing of knowledge: Guide, motivate and assist in the training and development of colleagues in residue chemistry, metabolism, and bioanalysis, as needed.
- Adhere to the policies and procedures in the areas of Good Laboratory Practice, business conduct, and general safety.
Education Minimum Requirement:
- Ph.D or D.V.M. with at least seven years of experience in analytical chemistry, biochemistry, or a closely-related discipline.
Required Experience and Skills:
- A working understanding of domestic and international veterinary drug development for companion and food animals
- Experience in conducting, monitoring, reviewing and/or summarizing residue chemistry, metabolism and bioanalytical studies to support domestic and international registration of pharmaceuticals
- Experience in HPLC-UV/VIS/FL and LC-MS/MS method development and analysis as it pertains to residue chemistry and bioanalysis
- Experience with Good Laboratory Practices (GLPs)
- Knowledge of standard computer software applications for general office work (word processing, presentation, and spreadsheet)
- Excellent verbal and written communication skills required, with good attention to details; Team player with strong inter-personal skills
- Domestic and international travel required
Preferred Experience and Skills:
- Extensive knowledge of US-FDA, EU-CVMP and other regulatory agency scientific guidelines for conducting metabolism, pharmacokinetics, and residue chemistry studies of veterinary pharmaceuticals.
- Experience with conducting regulatory surveillance method trials required by US-FDA.
- Experience in pharmacokinetics and mammalian toxicology is also desired.
- Experience in managing junior level scientists is considered a plus, but not mandatory.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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