BioLegacy Research · 5 months ago
Bioanalytical Scientist – PK/TK Assay Development
San Diego, CA
Full-time
Onsite
Mid Level
$100K/yr - $150K/yrBioLegacy is a leading preclinical contract research organization dedicated to delivering high-quality research services to support drug development. They are seeking a highly skilled Preclinical Bioanalytical Scientist to focus on the development and validation of pharmacokinetic and toxicokinetic assays for preclinical studies, involving designing, optimizing, and validating bioanalytical assays using MSD and ELISA platforms.
Biotechnology
Responsibilities
Design, develop, and validate bioanalytical assays for PK and TK studies, primarily utilizing MSD and ELISA platforms
Optimize assay conditions and perform method validation in accordance with regulatory guidelines (FDA, ICH, EMA) for GLP-compliant studies
Analyze and interpret PK/TK results
Prepare detailed reports documenting assay performance, validation, and data analysis for internal teams and external collaborators
Work closely with cross-functional teams, including pharmacokinetics, toxicology, and regulatory affairs, to align on project timelines, deliverables, and regulatory requirements
Identify, address, and resolve technical issues encountered during assay development or validation to ensure reproducible and reliable results
Ensure compliance with GLP regulations and guidelines for preclinical PK/TK studies
Contribute to the development of new technologies and methodologies to enhance assay performance, throughput, and efficiency
Qualification
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
Company
BioLegacy Research
BioLegacy Research (formerly BTS Research) provides comprehensive preclinical research services, including GLP and non-GLP toxicology, pharmacokinetics, and specialized NHP and large-animal studies.
Founded in 2007
11-50 employees
Funding
Current Stage
Early StageRecent News
2025-02-17
Company data provided by crunchbase