Principal Scientist - BioPharma Sciences (LBA)

The Steely Group; Olathe (KS); Presencial; USD 110.000 - 160.000; Jornada completa

Descripción de la vacante

The Steely Group's client seeks a Principal Scientist, BioPharma Sciences to guide complex bioanalytical studies and assay development. You will design strategies, solve technical challenges, and ensure high-quality data delivery to clients.

You will lead ligand binding and cell-based assays (ELISA, MSD), mentor scientists, interact with QA for GLP compliance, and collaborate with cross-functional teams to expand BioPharma capabilities and drive project success.

Formación

• PhD or highest degree in a biology-related field with GLP laboratory experience.
• Experience leading bioanalytical studies and assay development.
• Strong ability to communicate complex data to clients.

Responsabilidades

• Lead design, development, qualification, validation, and troubleshooting of LBA and cell-based assays.
• Provide scientific leadership and direction throughout study execution.
• Mentor scientists and provide technical guidance across projects.
• Ensure data integrity, quality, and GLP compliance in all studies.

Conocimientos

LBA strategy

Scientific leadership

Mentoring

Client communication

Educación

PhD in Biology/Biochemistry/Immunology

Herramientas

ELISA

MSD

Descripción del empleo

Further our client’s mission by serving as a scientific and technical leader for complex bioanalytical studies and assay development programs.

The Principal Scientist, BioPharma Sciences (LBA) will apply their deep expertise in ligand binding and cell-based assays to design scientific strategies, solve complex technical challenges, guide study execution, and ensure the delivery of high-quality scientific data to our clients.

The BioPharma Sciences team uses ligand binding assay (LBA) platforms to conduct bioanalytical testing in support of drug discovery, preclinical, and clinical studies, including the quantification of proteins, biomarkers, and anti-drug antibodies in biological matrices using technologies such as ELISA, MSD, and other immunoassay-based methods.

Responsibilities Include

• Serve as a scientific and technical expert for complex bioanalytical programs involving neutralizing antibody (NAb), cell-based, biomarker, pharmacokinetic (PK), and anti-drug antibody (ADA) assays
• Lead the design, development, optimization, qualification, validation, and troubleshooting of ligand binding and cell-based methods
• Design experimental strategies, interpret complex scientific data, and provide scientific direction when assays or studies encounter technical challenges
• Provide scientific leadership throughout study execution, ensuring appropriate experimental design, data integrity, scientific rigor, and timely delivery
• Serve as a senior scientific resource to clients, providing technical consultation, communicating study strategy and results, and recommending solutions to complex bioanalytical challenges
• Act as a technical resource and mentor to Scientists and Senior Scientists, providing scientific guidance, training, and support for assay development and study execution
• Partner with scientific leadership and cross-functional teams to evaluate new technologies, methodologies, and approaches that expand or improve BioPharma Sciences capabilities
• Interact with Quality Assurance to resolve complex audit or study issues and ensure work is conducted in accordance with applicable protocols, SOPs, and GLP regulatory requirements
• Review and provide scientific oversight of protocols, data, reports, and other study documentation for accuracy, quality, and scientific validity
• Support continuous improvement of scientific processes, technical capabilities, and laboratory practices
• Perform all aspects of the job in a way that supports company brand and supports company mission, vision, and values

Requirements / Qualifications

• Bachelor’s, Master’s, or PhD in Biology, Biochemistry, Immunology, or related scientific field with significant experience in a bioanalytical laboratory environment
• Extensive hands-on experience working in a GLP-regulated laboratory environment
• Deep technical expertise with ligand binding assays (LBA), including ELISA, MSD, or similar immunoassay platforms
• Demonstrated hands-on experience with all the following assay types: Neutralizing antibody (NAb) assays, Cell-based assays, Biomarker assays, Pharmacokinetic (PK) assays, Anti-drug antibody (ADA) assays
• Extensive experience with bioanalytical method development, optimization, qualification, validation, and troubleshooting
• Strong understanding of assay performance characteristics, including precision, accuracy, sensitivity, selectivity, specificity, and robustness
• Demonstrated ability to independently troubleshoot complex assay performance issues and develop scientifically sound solutions
• Experience providing scientific leadership and technical consultation for complex bioanalytical studies and programs
• Strong client-facing experience with the ability to communicate complex scientific information and provide technical recommendations
• Experience interacting with Quality Assurance and supporting audits and inspections
• Demonstrated ability to mentor and provide technical guidance to scientists at varying levels of experience