Bioanalytical Scientist – PK/TK Assay Development

Bioanalytical Scientist – PK/TK and Assay Development and Validation

Location: San Diego, CA, USA

Who We Are

BioLegacy, part of the PharmaLegacy family, is a leading preclinical contract research organization (CRO) dedicated to delivering high-quality, GLP-compliant research services to support drug development. Our team of passionate scientists partners with clients across the globe to provide innovative solutions in bioanalysis, immunology, oncology, and more. We are committed to scientific excellence, regulatory integrity, and helping our partners bring life-changing therapies to patients faster.

Overview

We are seeking a highly skilled and motivated Preclinical Bioanalytical Scientist to join our Bioanalytical team, focusing on the development and validation of pharmacokinetic (PK) and toxicokinetic (TK) assays for preclinical studies. The primary responsibilities will involve designing, optimizing, and validating bioanalytical assays using the MSD (Meso Scale Discovery) and ELISA platforms to support PK/TK assessments.

This is a key role in supporting drug development programs from early discovery through preclinical development. The ideal candidate will have hands-on experience in PK/TK assay development and validation in a GLP-regulated environment, with proficiency in MSD and ELISA technologies. This role will involve close collaboration with internal and external teams to ensure timely and high-quality results.

Key Responsibilities

PK/TK Assay Development: Design, develop, and validate bioanalytical assays for PK and TK studies, primarily utilizing MSD and ELISA platforms. Ensure assays are fit for purpose and meet regulatory requirements.

Method Optimization & Validation: Optimize assay conditions and perform method validation in accordance with regulatory guidelines (FDA, ICH, EMA) for GLP-compliant studies. Conduct bioanalytical method validation and qualification to support PK/TK studies.

Data Analysis & Reporting: Analyze and interpret PK/TK results. Prepare detailed reports documenting assay performance, validation, and data analysis for internal teams and external collaborators.

Collaboration: Work closely with cross-functional teams, including pharmacokinetics, toxicology, and regulatory affairs, to align on project timelines, deliverables, and regulatory requirements.

Troubleshooting & Problem-Solving: Identify, address, and resolve technical issues encountered during assay development or validation to ensure reproducible and reliable results.

Regulatory Compliance: Ensure compliance with GLP regulations and guidelines for preclinical PK/TK studies. Provide complete and accurate documentation to support regulatory submissions.

Continuous Improvement: Contribute to the development of new technologies and methodologies to enhance assay performance, throughput, and efficiency. Identify and implement automation solutions where appropriate.

Qualifications

Required:

Bachelor’s or Master’s degree in life sciences, Pharmacology, or a related field with relevant industry experience; Ph.D. preferred.

Strong hands-on experience in PK/TK assay development and validation using MSD and ELISA platforms.

Proven experience working in a GLP-compliant environment, including preparation of method validation reports and study documentation.

Knowledge of FDA, ICH, and EMA guidelines for bioanalytical method validation and PK/TK studies.

Proficiency in analyzing PK/TK data using SoftMax, as well as other statistical and data visualization tools.

Strong written and verbal communication skills, with the ability to present scientific findings to internal and external stakeholders.

Ability to work collaboratively in a fast-paced, team-oriented environment while managing multiple projects.

Preferred

Experience with other bioanalytical platforms such as Luminex, PCR, or LC-MS/MS.

Familiarity with automation platforms for PK/TK assays.

Equal Opportunity Employer

BioLegacy, part of the PharmaLegacy family, is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are made based on qualifications, merit, and business needs without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.