Senior Scientist, Pharmacokinetics GLP Bioanalytics
Job Description New hires in Non-Field based roles in the U.S. & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, non-office based roles who routinely collaborate with external stakeholders such as employees in customer facing commercial or research based roles will be required, subject to applicable law, to be fully vaccinated as a condition of employment. Our Development team ensure production can be scaled up whilst remaining stable, effective, deliverable and safe. Following formulation, cutting edge computer modelling techniques are used to simulate outcomes and, if successful, PKPD and toxicity studies bring the science one step closer to giving hope to patients. The Global Bioanalytics Group within Preclinical Development is seeking a senior level bioanalytical scientist to join the Regulated GLP PK Bioanalytical group. This position will be based in West Point, PA. In this position, you will develop, optimize, validate, and utilize chromatographic tandem mass spectrometric assays and ligand binding assays to measure drug levels in biological matrices to support sample testing. In addition, you will evaluate new bioanalytical technologies for Good Laboratory Practice and clinical application. Primary
Responsibilities:
Be responsible for method validation, method trouble-shooting, and preclinical sample analysis. Ensure GLP compliance. Support assay protocol and validation report preparation. Support assessment and implementation of new bioanalytical technologies for PK assays Communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to write technical reports, and to participate on cross-functional teams Education Minimum Requirement:
PhD in Chemistry, Biochemistry, Analytical Sciences or related areas or Bachelor's Degree with 10
years experience. Required Experience and Skills Knowledge regarding the development, validation, and troubleshooting of chromatographic tandem mass spectrometric and ligand binding assays including bioanalysis of large molecules by mass spectrometry. A team player with excellent oral and written communication skills as evidenced by scientific publications and presentations at scientific meetings. Familiarity with the basic principles of regulated bioanalysis and Good Laboratory Practice Experience supporting the bioanalysis of different biotherapeutic modalities Preferred Experience and Skills:
Experience in LBA-based bioanalytical method development and sample testing. Ability to work independently and act as a scientific mentor for development and validation of bioanalytical assays. Track record in developing ligand binding assays for pre-clinical and/or clinical applications. Experience with oligonucleotides and other gene therapy related modalities in a bioanalytical laboratory Familiarity with liquid handlers and other automation platforms for sample preparation and assay process. Familiarity with the drug development process Familiarity with drug metabolism and/or the basics of toxicology
Salary Range:
$100K -- $150K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Be responsible for method validation, method trouble-shooting, and preclinical sample analysis. Ensure GLP compliance. Support assay protocol and validation report preparation. Support assessment and implementation of new bioanalytical technologies for PK assays Communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to write technical reports, and to participate on cross-functional teams Education Minimum Requirement:
PhD in Chemistry, Biochemistry, Analytical Sciences or related areas or Bachelor's Degree with 10
years experience. Required Experience and Skills Knowledge regarding the development, validation, and troubleshooting of chromatographic tandem mass spectrometric and ligand binding assays including bioanalysis of large molecules by mass spectrometry. A team player with excellent oral and written communication skills as evidenced by scientific publications and presentations at scientific meetings. Familiarity with the basic principles of regulated bioanalysis and Good Laboratory Practice Experience supporting the bioanalysis of different biotherapeutic modalities Preferred Experience and Skills:
Experience in LBA-based bioanalytical method development and sample testing. Ability to work independently and act as a scientific mentor for development and validation of bioanalytical assays. Track record in developing ligand binding assays for pre-clinical and/or clinical applications. Experience with oligonucleotides and other gene therapy related modalities in a bioanalytical laboratory Familiarity with liquid handlers and other automation platforms for sample preparation and assay process. Familiarity with the drug development process Familiarity with drug metabolism and/or the basics of toxicology
Salary Range:
$100K -- $150K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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