Senior Scientist Pharmacokinetics

Location: West Point

Job Description Senior Scientist - Exploratory Vaccines and Regulated Robotics We are seeking a highly motivated Senior Scientist to join the Exploratory Vaccines and Regulated Robotics team within the Department of Regulated Bioanalytics at our company. Our team is dedicated to developing, validating, and implementing assays used to evaluate vaccine and biologic candidates in clinical studies. This is an exciting opportunity to lead hands-on development, optimization, qualification, and clinical-study implementation of immunology-based assays, with an emphasis on cellular assays that assess functional T-cell and B-cell responses, and innate immune activation.

Join us in applying laboratory science, automation, and data-driven decision-making to strengthen bioanalytical support for vaccine and biologics programs.

Responsibilities Lead assay lifecycle activities for cell-based immunoassays, including design, execution, optimization, qualification, implementation, troubleshooting, documentation, and transfer readiness for preclinical and clinical samples.

Develop and apply cellular immunology methods, including intracellular cytokine staining, ELISpot/Fluoro Spot, cytokine profiling, and related functional assays to characterize immune responses.

Support flow cytometry instrument readiness by performing calibrations, routine maintenance, troubleshooting, and coordination with vendors or operations teams for service and repair.

Author and review SOPs, test methods, qualification documents, technical reports, and scientific presentations; communicate assay strategy, data interpretation, technical risks, limitations, and recommendations to internal stakeholders, cross-functional teams, and external scientific audiences.

Apply laboratory experimentation, data analytics, automation, robotic liquid handling, and risk-based troubleshooting to improve assay performance, workflow efficiency, data quality, and overall bioanalytical capability.

Serve as an internal subject matter expert by providing scientific rationale, technical guidance, training, and mentoring to colleagues, junior scientists, and contractors.

Work effectively in a regulated GxP environment by maintaining accurate, contemporaneous, and complete documentation; supporting data integrity; and ensuring assay activities are conducted in accordance with applicable SOPs, test methods, and regulatory expectations.

Qualifications Required Ph .D. in immunology, cell biology, biology, bioengineering, or a related scientific discipline; or M.S. with 2+ years of relevant industry experience; or B.S. with 5+ years of relevant industry experience.

Ability to work safely with viruses, bacteria, and potentially infectious human and animal samples under BSL-2 laboratory practices.

Experience working in, or strong understanding of, regulated bioanalytical workflows, GxP documentation practices, assay development, qualification/validation expectations, and data integrity principles.

Strong scientific judgment, experimental design, and troubleshooting skills, with the ability to independently identify root causes, assess technical risk, and recommend scientifically sound next steps.

Strong interpersonal, verbal, and written communication skills, including the ability to clearly communicate assay strategy, technical risks, data interpretation, and recommendations to scientific and cross-functional stakeholders.

Strong attention to detail, organizational skills, and ability to manage multiple studies, assay development activities, and documentation deliverables simultaneously.

Relevant experience in immunology, cell-based assay development, or regulated bioanalytical assay development.

Preferred Experience with human PBMC isolation, cryopreservation, thawing, culture, and maintenance of primary immune cells and/or relevant cell lines.

Broad experience assessing immune cell function using multiparameter flow cytometry, intracellular cytokine staining, T-cell and B-cell ELISpot/Fluoro Spot, multiplex cytokine platforms, and related cellular immunology methods.

Hands-on experience developing, optimizing, and analyzing multicolor flow cytometry panels, including gating strategy development, compensation, controls, and interpretation of complex datasets.

Experience with liquid handlers, automated sample preparation workflows, data analytics, and other automation or digital tools used to improve assay consistency, throughput, data quality, and process robustness.

Working knowledge of standard data…