Associate Principal Scientist, Bioanalytical Regulated Immunogenicity and Molecular

Job Description

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

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 Associate Principal Scientist to join the Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalysis (PDMB) in the area of Bioanalytical Regulated Immunogenicity and Molecular. Our team is modernizing Bioanalytics with regulated end-to-end automation, data tracking, analysis, and visualization, and automated liquid handling.  The primary role of the successful candidate will be to design and develop immunology-based preclinical and clinical assays for our vaccines pipeline. The individual will be responsible to lead vaccine bioanalytical assay development, qualification/validation, technology transfer, and/or troubleshooting to meet regulatory expectations for validation and line of sight for life-cycle maintenance. Importantly, the successful candidate will have a proven track record for developing bioanalytical assays with a close hands-on connection to laboratory activities. The candidate should be current on state-of-the art technologies and champion the evaluation of new technologies and optimization of processes. Providing leadership and mentorship to junior staff, building relationships with stakeholders, and providing expert technical representation on multidisciplinary teams will be expected.

Responsibilities:

• Provide scientific input and strategy to design of immunoassays such as Luminex, Mesoscale, and/or cell-based functional immunogenicity assays preclinical and clinical regulated studies.

• Method development, qualification/validation, troubleshooting and/or assay format selection based on risk assessment and fit-for-purpose considerations. Support of pre-clinical/clinical sample analysis as needed.

• Understand, leverage, and implement different automation strategies including Biomek, Hamilton, or Tecan liquid handlers to reduce hands-on time and increase throughput.

• Strong scientific background and interest in associated laboratory experimentation.

• Assess and implement new technologies with consideration for longevity and problem solving.

• Serve as an internal subject matter expert on developed assays, providing technical support to internal and external laboratories working to implement assays.

• Ensure assays are developed and executed in compliance with applicable regulatory guidance. Develop assay protocols, qualification plans, and reports. Address QA findings and observations.

• Contribute to regulatory filings and responses pertaining to assay details as needed.

• 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.

• Adherence to basic safety procedures in a BSL2 laboratory and compliance to regulations.

Qualifications:

Minimum education required:

• PhD in Biological Sciences such as Virology, Immunology, Cell biology or related area with 4+ years, or a Masters degree with 8+ years, or a Bachelor degree with 12+ years of experience in the field of relevant experience in the development and execution of assays in a regulated bioanalytical environment.

Required experience and skills:

• Subject matter expert in the field of regulated analytical and/or bioanalytical development of cell-based or ligand-binding-based assays.

• Experience with experience with immunology assays such as ELISA, AlphaLISA, multiplexed ligand binding assays (LBA) on Mesoscale and/or Luminex platforms.

• Deep knowledge and expertise in development, qualification/validation, and troubleshooting of regulated cell-based or ligand binding-based assays. Track record in designing assays for pre-clinical and/or clinical applications.

• Familiarity with