Senior Scientist Pharmacokinetics

Merck; Spring House (PA); On-site; USD 130,000 - 170,000; Full time

Job summary

Merck seeks a Senior Scientist to lead hands-on development and validation of immunology-based assays for vaccines in a regulated bioanalytics setting. You will design and optimize cell-based assays, perform intracellular cytokine staining and ELISpot/FluoroSpot, and manage documentation in a GxP environment.

Own assay transfer readiness from development to clinical studies, mentor junior scientists, and collaborate with cross-functional teams to ensure data quality and regulatory compliance.

Qualifications

• Ph.D. in immunology, cell biology, biology, bioengineering, or related scientific discipline; or M.S. with 2+ years of industry experience; or B.S. with 5+ years of industry experience.
• Ability to work safely with viruses, bacteria, and potentially infectious human and animal samples under BSL-2 practices.
• Experience with regulated bioanalytical workflows, GxP documentation, assay development/validation, and data integrity.

Responsibilities

• Lead cell-based immunoassay lifecycle activities for preclinical and clinical samples.
• Develop cellular immunology methods like ICS, ELISpot/FluoroSpot, and cytokine profiling.
• Maintain flow cytometry readiness through calibration and maintenance.
• Author and review SOPs, test methods, and technical reports; communicate strategy and risks.

Skills

Cytometry

GraphPad Prism

Immunoassays

Immunology Research

Ligand Binding Assay

Pharmacokinetics

Pharmacology

Sample Preparations

Scientific Presentations

Scientific Research

Scientific Writing

Technical Reviews

Vaccine Development

Education

Ph.D. in immunology, cell biology, biology, bioengineering, or related field

M.S. with 2+ years of industry experience

B.S. with 5+ years of industry experience

Tools

Flow cytometer

Liquid handling robots

FlowJo

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/FluoroSpot, 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/FluoroSpot, 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 analysis and visualization tools such as FlowJo, GraphPad Prism, Microsoft Excel, PowerPoint, and related scientific software.

Required Skills

• Cytometry
• GraphPad Prism
• Immunoassays
• Immunology Research
• Ligand Binding Assay
• Pharmacokinetics
• Pharmacology
• Sample Preparations
• Scientific Presentations
• Scientific Research
• Scientific Writing
• Technical Reviews
• Vaccine Development