TheDepartment of Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) is seeking an experiencedbioanalyticalscientist to join the RegulatedPKBioanalyticalgroup. This position will be based in West Point, PA.
In this position, youwill develop, optimize, validate andutilizeligand-binding assays (LBA) to measuredrug levels in biological matrixto support pre-clinical GLP studies as well as clinical studies.You willprovide scientific oversight of development and validation of newPKassaysandevaluate newbioanalyticaltechnologiesfor GLP and clinical application.
In this exciting role, you will:
- Be responsible for method development, validation, trouble-shooting, and/or pre-clinical/clinical sample analysis as needed
- Provide scientific supervision in PK LBA method development and optimization
- Screenreagents to support PKLBAdevelopment
- Ensure GLP compliance. Supportassayprotocol andvalidationreport preparation. Address QA findings and observations
- Assessand implement newLBAtechnologiesforPK assays
- Serve as an internal subject matter expert on developed assays, providing technical support, as needed to internal and external laboratories working to implement assays
- Author regulatory filings and respond to regulatory authority questions pertaining to bioanalytical strategy and execution
- Communicate results effectively in presentations to stakeholders in partner organization at external scientific meetings, to write technical reports and to participate on cross-functional teams.
Education Minimum Requirement:
- PhD in Biological Sciences such as Microbiology, Immunology, and Biochemistry, or related area witha minimum of 3 years, OR a Master's degree with a minimum of 5 years OR Bachelor's degree witha minimum of 8years of relevant experienceinthe development andexecution of ligand binding assays in a regulated bioanalytical environment.
Required Experience and Skills
- Deep knowledge and expertise in development, validation, and troubleshooting of ligand binding assays.
- Track record in designing ligand binding assays forpre-clinical and clinicalapplications.
- Experience inmultipleimmunoassayplatformssuch as MSD, Gyros, Luminex, ELISA, orAphaLISA.
- A team player with excellent oral and written communication skillsas evidenced by scientific publications and presentations at scientificmeetings.
- Ability to work independently and as a scientific mentor for development and validation of assays.
Preferred Experience and Skills:
- Knowledge ofRegulated Bioanalysis andGood Laboratory Practice (GLP)
- Experience in LC-MS based bioanalytical method development and sample testing.
- Familiarity with liquid handlers and other automation platforms for sample preparation and assay process.
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.
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Flexible Work Arrangements:
Valid Driving License:
Yes; Biohazadous materials (Biosafety level 2)
Number of Openings: