Scientist – Vaccine Life Cycle Management

Job Requirements

Scientists in the Immunogenicity and Molecular Bioanalytics team within Pre-Clinical Development Regulated Bioanalytical contribute to the vaccine and biologic therapeutic area through assay development, optimization, qualification/validation, pre-clinical and clinical testing. This specific position will support the vaccine lifecycle management team, and the individual should have a comprehensive knowledge of the principles and concepts of immunology as it pertains to bioanalytical method development and clinical testing. The successful candidate will provide input into the design of experiments, evaluate new techniques, leverage robotic systems, contribute to optimization and troubleshooting of assays, method qualification/validation, and testing clinical samples as needed. The responsibilities of the Scientist will be to work collaboratively in a fast-paced regulated environment to contribute to the modernization of vaccine clinical assays.

Responsibilities:

· Provide scientific laboratory support for the design of customized immunoassays such as ELISA, ELISpot, molecular and/or cell-based assays supporting licensed vaccine products

· Support method development, validation, assay bridging, troubleshooting and/or assay format selection based on knowledge of vaccine lifecycle management and under the guidance of a subject matter expert

· Generation of quality data to support clinical studies with full accountability for data generated

· Communicate results effectively

· Ensure assays are developed and executed in compliance with applicable Guidance and Regulations. Contribute to assay protocol, validation report, and/or study report preparation. Address QA findings and observations.

Education Minimum Requirements:

· Master’s degree in Biological Sciences such as Virology, Immunology, Cell biology or related area

· Bachelor’s degree with 3+ years of experience in the relevant field of development and validation of assays in a regulated environment

Required Experience:

· Experience in the field of regulated analytical and/or bioanalytical development and qualification/validation of antigen-specific antibody binding assays (ELISA, AlphaLISA, multiplex company, or Luminex)

· Alternatively, or in addition, experience with molecular and/or functional antibody assays (cell-based virus neutralization, OPK/MOPA, infectivity assays)

· Good verbal and written communication skills

· Ability to follow procedures and thoroughly document experiments

· Strong organizational and project management skills

Preferred Experience and Skills:

· Familiarity with liquid handlers and other automation platforms for sample preparation and assay process

· Knowledge in development, Design of Experiments (DoE), and qualification/validation for regulated vaccine analytical or bioanalytical assays

· Experience with GxP as it applies to regulated bioanalysis

· Use of electronic laboratory notebooks

#PCDBioanalytical

Requisition ID:P-100546