Associate Principal Scientist, Pharmacokinetics

Job Description

Job Location: Springhouse, Pennsylvania

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people 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.

We are seeking a highly motivated Senior Scientist to join the Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalysis (PDMB) in the area of Regulated Bioanalytical Exploratory Development. Our team is exploring clinical and preclinical immune responses to vaccination leveraging modern automation, serological, and cell-mediated immunological methods. The successful candidate will design, develop, and support bioanalytical vaccine immunogenicity assays to support regulated preclinical and clinical vaccine development. The individual will be responsible to contribute and lead all hands-on laboratory aspects of bioanalytical assay development, qualification, technology transfer, and/or troubleshooting. The candidate will have a strong background in immunology and associated assays to measure immune responses to vaccination. Preferably, the successful candidate should have a proven track record of understanding immune responses as well as selecting and designing applicable assays capable to meet regulatory expectations for vaccine or biologics development. The candidate should be current on state-of-the art technologies and is expected to champion applied evaluation of new technologies and lead implementation to expand vaccine response knowledge, increase throughput, reduce turn-around times, and provide quality data. Providing expert technical representation on multidisciplinary teams will be expected.

Responsibilities

• Leverage a strong scientific background to design, develop, and support ligand binding assays and/or cell-mediated immunogenicity assays.

• Responsible for the execution of method development, qualification, troubleshooting and/or pre-clinical/clinical sample analysis.

• Operation, understanding, and utilization of automated equipment.

• Contribute to the assessment and implementation of new analytical technologies with a focus on applied problem-solving and tangible improvements.

• Understand and adhere to regulated frameworks and guidances in collaboration with team leads.

• Serve as an internal subject matter expert on immunological background and laboratory aspects of bioanalytical development.

• Holistically, systematically, and efficiently analyze data, determine trends, and communicate to teams and leadership.

• Strong understanding of systematic scientific concepts and interest in associated hands-on laboratory experimentation.

• Follow compliance requirements including GxP regulations. Contribute to assay protocol and report preparation. Adherence to basic safety procedures in a BSL2 laboratory.

Qualifications:

• PhD in Biological Sciences or related area with 0-3 years, or a MS degree with 4+ years, or a BS degree with 7+ years

• In-depth scientific knowledge of immunology including cell-mediated immunity.

• Knowledge and expertise in assay development, qualification, and troubleshooting of ligand binding immunogenicity assays and/or experience with cell-mediated immunogenicity assays.

• Critical scientific thinking and systematic trouble-shooting skills.

• Basic knowledge of statistical data evaluation and graphing.

• Good verbal and written communication skills to explain and 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.

• Ability to follow procedures and regulations, and thorough, detail-oriented documentation.

• Familiarity with liquid handlers and other automation platforms such as Biomek, Hamilton, or Tecan liquid handlers for sample preparation and assay process is preferred.

• Familiarity with Regulated Bioanalysis and regulations as pertain to bioanalysis are desired.

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