Scientist, Pharmacokinetics

Merck•Upper Gwynedd Township, PA

1d•Hybrid

About The Position

Our Company is a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development. The role involves executing defined outsourcing activities for assigned studies or program components, supporting CRO/vendor relationship management, reviewing proposals and reports, contributing to inspection readiness, and assisting with CRO onboarding and site visits. The position also includes identifying risks, participating in continuous improvement initiatives, and networking with Subject Matter Experts to ensure quality expectations are met.

Requirements

Bachelor’s degree in Biology, Cell Biology, Immunology, Biochemistry or related field with 2 years of experience in immunoassay techniques including ligand binding assays, cell-based functional and neutralization assays, and/or molecular assays, specializing in vaccines method development and validation, or Master’s degree
Experience in bioanalytical development and validation and/or quality control (QC) with knowledge of regulatory expectations for operating in a regulated clinical testing environment
Ability to manage defined project components with guidance
Strong organizational, communication (oral and written), and teamwork skills
Familiarity with automated processes, automated data workflows and/or AI-assisted tools in a scientific or data-driven environment, with openness to expanding technical capabilities
Experience with one or more of the following techniques: Ligand binding assays, Cell-based functional or neutralization assays, PCR/RT-PCR
Assay
Assay Development
Bioanalysis
Biochemical Analysis
Biochemical Assays
Biochemistry
Cell Culture Techniques
Clinical Judgment
Data Analysis
Data Visualization
Detail-Oriented
Ethical Compliance
GMP Documentation
Good Laboratory Practices (GLPs)
Immunoassays
Ligand Binding Assay
Meeting Planning
Operational Excellence
Pharmacodynamics
Pharmacotherapeutics
Project Management

Nice To Haves

2+ years of experience working in a regulated assay environment and familiarity with FDA bioanalytical guidance requirements

Responsibilities

Execute defined outsourcing activities for assigned studies or program components
Support CRO/vendor relationship management, including meeting coordination, documentation, and timelines
Review proposals, protocols, test methods, and bioanalytical reports for accuracy, completeness, and compliance
Contribute to inspection readiness through adherence to established processes and documentation practices
Support CRO onboarding, contracting workflows, and coordination with Research Procurement
Assist with preparation and participation in CRO site visits and performance reviews
Identify risks or performance concerns and escalate appropriately with proposed mitigation options
Participate in continuous improvement initiatives across outsourcing operations
Identify process inefficiencies or pain points and propose improvement ideas
Adopt and reinforce standardized processes, tools, templates, and metrics
Support implementation of new workflows, systems, or operating models
Networking and partnership building with Subject Matter Experts (SMEs) to guide the science so our Company's quality expectations are achieved