New Jersey

Associate Principal Scientist, Drug Safety & Metabolism

Job description          

Job Description Our Animal Health Research Laboratories team work tirelessly to invent solutions to improve the health and wellbeing of animals. Our state-of-the-art research facilities create an environment of innovation that enable us to create breakthrough science changing the way we approach animal health challenges. Responsible for defining/designing, conducting and/or technical support of target animal safety, pharmacokinetic, metabolism, and residue studies and human safety programs to support world-wide registrations of veterinary pharmaceuticals. This position is part of Drug Safety and Metabolism, Global Preclinical Development, based in Madison, New Jersey. The ideal candidate will: Define preclinical programs needed for registration and marketing of companion and food animal pharmaceuticals. Target species include: dogs, cats, horses, beef and dairy cattle, chickens, pigs, sheep, goats and fish. Human Safety: Programs may include a range of studies, such as toxicology, metabolism, and residue depletion studies, and exposure/risk assessment in support of user/handler safety. Target Animal Safety: Programs may include dose tolerance / margin of safety studies, injection site irritation, and reproduction safety studies. Special Studies or Issues: May design and conduct special studies or literature reviews to address specific safety issues (excipients, impurities, leachables/extractables, etc.). Study programs may require: Study design/protocol development, placing studies at contract research organizations (CROs), study monitoring, data/report review and raw data preparation for health authority submissions, and problem issue resolution. Key to the support of study programs is to ensure data accuracy, integrity, and proper data interpretation and discussion as well as to inform internal customers of study progress and any critical issues. Interact with regulatory agencies to address concerns with products currently in development or marketed products, including preparation of expert reports, position papers, formal presentations, etc., for regulatory agencies. Maintain technical and professional expertise by staying abreast of developments in the field and sharing that information with the appropriate areas of Intervet Inc. (d/b/a Merck Animal Health). Maintain knowledge of regulatory and compliance requirements for areas of responsibility. Adhere to the policies and procedures in the areas of Good Laboratory Practice, business conduct, and general safety. Education Minimum Requirement: D.V.M. with at least two to four (2-4) years of experience in Preclinical toxicology/pharmacology, biology, chemistry, biochemistry, or equivalent combination of education, training and relevant experience. Required Experience and Skills: A working understanding of domestic and international veterinary drug development for companion and food animals Proven experience in designing developmental and regulatory approaches for companion and food animal drugs Experience conducting, monitoring, reviewing and/or summarizing preclinical studies to support registration of veterinary/companion animal pharmaceuticals A working knowledge of placing, monitoring and obtaining solid scientific products or reports from CROs A working knowledge of the Good Laboratory Practices (GLP's) Excellent verbal and written communication skills required, with good attention to details; Team-player with strong inter-personal skills Knowledge of standard computer software applications for general office work (WORD, Power Point, Excel) Preferred Experience and Skills: A working understanding of domestic and international veterinary drug development and various agribusiness practices affecting companion and food animals, including aquaculture, is desirable. A PhD in addition to a DVM is desirable. Our Animal Health division is a trusted global leader in veterinary medicine, dedicated to the health and well-being of animals. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society and our planet. We offer one of our industry’s most innovative portfolio of products, services and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species. Who we are … Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development. What we look for … In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth. INVENT. IMPACT. INSPIRE. #LI-JS1 NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. #LI-JS1 If you need an accommodation for the application process please email us at staffingaadar@merck.com
MERCUS New Jersey jobs

MERCUS

New Jersey jobs

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