Principal Scientist, Cell-Mediated Immunity

Job Description

Job Description:

We are seeking a highly motivated and experienced Principal Scientist with established expertise in cell-mediated immunology to join the Regulated Bioanalytics Immunogenicity and Molecular team within the Department of Pharmacokinetics, Dynamics, Metabolism & Bioanalytics (PDMB) at our research site in Springhouse, PA. The successful candidate will have a proven track record in the design, development and interpretation of cellular immunology methodologies to characterize functional T-cell and B-cell subsets and innate immunity for evaluation of vaccines and immuno-oncology therapies.  In addition to deep immunological expertise, the candidate will be expected to provide leadership and mentorship to junior staff, build relationships with stakeholders, and provide expert technical representation on multidisciplinary teams. The candidate should be current on state-of-the art technologies and embrace the evaluation of new technologies and automation.

Responsibilities include, but are not limited to:

• Represent the PDMB group in early through late product development teams and influence bioanalytical strategies together with stakeholders.

• Provide scientific input to design, execution, troubleshooting and interpretation of cellular immunoassays such as intracellular cytokine staining (ICS), ELISpot/FluoroSpot and cytokine profiling for preclinical and clinical studies.

• Communicate strategy, results and interpretation effectively to project teams and upper management.

• Lead and mentor scientists up to Ph.D. level to solve complex problems independently while helping them gain confidence in decision-making and guiding them in career development.

• Hold self and team accountable for achieving program timelines and deliverables

• Understand and implement statistical analysis tools to lead group in complex multiparameter data analysis, interpretation and summary.

• Author regulatory filings and respond to regulatory authority questions pertaining to bioanalytical immunogenicity strategy and execution. 

• Remain current in the field and maintain an external presence in the field of cell-mediated immunity.

• Assess and implement novel approaches, such as new technology, automation, and bioinformatics approaches.

• Work collaboratively in a fast-paced regulated GxP environment and maintain the highest standards of documentation and quality in accordance with regulatory requirements.

Required experience and skills:

• Demonstrated expertise assessing antigen-specific immune cell function including multiparameter flow cytometry, intracellular cytokine staining analysis (ICS), T or B cell ELISpot/FluoroSpot, and multiplex assay platforms as evidenced by scientific publications and presentations at scientific meetings

• In-depth understanding of the vaccine development process and comprehensive knowledge of the principles and concepts of immunogenicity assay validation, clinical testing and regulatory submission for regulated vaccine bioanalytical assays and strategies.

• Supervision and mentorship of small teams with effective project management and commitment to career development of staff  

• Track record of innovation.  Experience implementing new technology or automation platforms.

• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.  Excel at working cross-functionally and gaining alignment on new ideas or strategies.

• Experience working in GxP regulated environment

• Excellent technical, communication (oral and written) skills with ability to manage projects independently and also work effectively within cross-functional teams.

Preferred experience and skills:

• Expertise in infectious disease vaccine development and/or Oncology/Immuno-Oncology cancer vaccine development

• Proficient in data analysis tools (FlowJo, Graph Pad Prism, Spotfire), Design of Experiments (DoE) and statistical analysis.

• Experience interpreting and visualizing large complex datasets (including RShiny, Python, D3)

• Hands-on experience with liquid handlers and end-to-end automation

• Hands-on experience in FACS/cell sorting

Education minimum requirements:

• PhD in Biological Sciences such as Immunology, Microbiology, Cell biology or related area with 8+ years, or a Masters degree with 10+ years, or a Bachelor degree with 14+ years of experience in the field of  cellular immunology

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