Analytical Scientist - Meet : Job Details

About the Company: A privately held, clinical stage biopharmaceutical company focused on developing therapeutic antibodies for the treatment of cancer, autoimmune, and other serious diseases. The management team and scientific advisors have extensive expertise in the discovery and development of specially engineered antibodies. The company's pipeline includes multiple programs from distinct, wholly-owned technologies, with a lead development candidate that targets specific cell types involved in hematologic malignancies and autoimmune disorders.

Function: Bioanalytical Sciences

Level: Senior Research Associate/Associate Scientist

Reporting Manager: Director, Bioanalytical Sciences

About the Opportunity: The company is seeking a highly motivated individual to serve as a Senior Research Associate/Associate Scientist in Bioanalytical Sciences. The successful candidate will work on pharmacokinetics (PK), immunogenicity, and biomarker assay development, qualification, sample analysis, and assay transfer to contract research organizations (CROs). This role offers exceptional opportunities for scientific and professional growth in a fast-paced, rapidly growing environment.

Role and Responsibilities:

• Development and qualification of PK, immunogenicity, and biomarker assays for clinical and nonclinical studies.
• Transfer of assays to CROs for full validation.
• Conduct sample testing in support of nonclinical pharmacology, toxicology, and PK studies (non-GLP).
• Manage in-house sample logistics and reagent inventory.
• Coordinate customized reagent generation and characterization.
• Support outsourced bioanalytical activities, providing assay reagents and GLP-related documents.
• Prepare and present assay results to project teams.
• Author assay qualification protocols and bioanalytical reports for non-GLP studies.
• Maintain accurate lab documents and training records.

Education, Experience and Qualification Requirements:

• BS/MS in biology or related fields, with 8+ years of industry experience.
• Experience in quantitative bioanalysis of large molecules, including assay development and sample analysis.
• Experience with immunogenicity analysis in clinical and preclinical settings.

Core Competencies, Knowledge and Skill Requirements:

• Knowledge of current GLP regulations and bioanalytical regulatory guidance.
• Strong analytical and problem-solving skills.
• Proficiency with Microsoft Office and bioanalytical software.
• Excellent communication skills and ability to work efficiently in a collaborative environment.
• Ability to multi-task and troubleshoot independently.
• Detail-oriented with good organizational and technical writing skills.