Principal Scientist, Pharmacokinetics and Immunogenicity (Biologics)
The Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) is seeking an experienced bioanalytical scientist to join our Regulated Pharmacokinetics (PK) Bioanalytical group located in West Point, PA. Demonstrated expertise in the field of the bioanalysis of biotherapeutics via ligand binding methods to support the PK and immunogenicity components of regulated drug development studies as well as experience in the development of immunogenicity risk assessments is required. In this position, you will be responsible for developing strategies and bioanalytical methods for measuring biotherapeutics, such as monoclonal antibodies, proteins, and antibody-drug conjugates, and assessing their immunogenicity in support of Good Laboratory Practice (GLP) and clinical studies.
Main Responsibilities include but are not limited to:
Conduct bioanalytical work to a high degree of quality and rigor, ensuring compliance with regulatory guidelines
Provide guidance and develop regulated bioanalytical methods for the quantitation of biotherapeutic drug candidates using ligand binding assay based platforms such as Meso-Scale Discovery, Gyrolab, Ella, and other emerging technologies
Contribute to immunogenicity risk assessment strategy; provide scientific guidance on internal and external immunogenicity assay development, qualification/validation and sample analysis, in support of preclinical and clinical studies
Represent the group on cross-functional project teams by serving as the bioanalytical subject matter expert (SME).
Author the bioanalytical components of regulatory submissions and drafting responses to regulatory questions
Present at internal and external scientific meetings
Education Minimum Requirements:
Ph.D. in Biology, Immunology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with a minimum of 7 years of relevant experience
Master’s Degree with a minimum of 10 years of relevant experience
Bachelors with a minimum of 14 years of relevant experience
Required Experience and Skills:
A minimum of 5 years of experience in developing and managing the development and utilization of ligand binding assays in support of regulated (GLP and clinical) pharmacokinetic and immunogenicity studies for drug development candidates
Prior experience preparing bioanalytical sections of regulatory submissions as well as experience interacting with regulatory agencies
Prior experience with scientific supervision of staff
In-depth understanding of the drug development process
Knowledge of the basic principles of regulated bioanalysis and Good Laboratory Practice (GLP)
Excellent verbal and written communication skills
Proven record of scientific publications and presentations at scientific meetings
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
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.
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