Scientist I, Bioanalytical

Our Client

Our client is an innovative, clinical-stage biopharmaceutical company that leverages a proprietary genetic architecture platform to understand the modifiers of disease. By combining advanced functional genomics, data science, and robust chemical libraries, they translate complex genetic insights into highly targeted, life-changing small molecule therapies. Focused on addressing metabolic, renal, and neurodegenerative disorders with significant unmet needs, they offer a culture driven by deep scientific curiosity, cross-functional collaboration, and rapid therapeutic translation.

The Opportunity

Are you a detail-oriented scientist with a passion for driving innovative therapies through preclinical and clinical pipelines?

Our client is seeking a Scientist to join their Non-Clinical Development team. In this pivotal role, you will provide critical oversight for bioanalytical work across non-GLP, GLP, and GCLP studies, directly contributing to key drug discovery and clinical milestones.

Reporting directly to the VP of Clinical Pharmacology and Non-Clinical Development, this position offers incredible cross-functional visibility, a collaborative culture, and the chance to make a tangible impact on patient lives.

The Impact You'll Have

• Assay Oversight: Oversee the development, validation, and execution of robust bioanalytical assays for both pharmacokinetics (PK) and pharmacodynamics (PD) across ongoing preclinical, nonclinical, and clinical programs.
• CRO & Vendor Management: Partner with and manage external contract laboratories conducting bioanalysis. Review raw data and batch analyses to ensure compliance, execution, and adherence to acceptance criteria.
• Regulatory Contributions: Author and provide technical, written summaries of bioanalytical methods for upcoming global regulatory submissions.
• Program Coordination: Align and coordinate regulated bioanalysis activities across the broader development portfolio, ensuring strict adherence to project timelines and global regulatory standards.
• Cross-Functional Collaboration: Provide routine timeline updates to leadership and collaborate directly with internal stakeholders across Research, Regulatory Affairs, Manufacturing, Quality, and Clinical Sciences to swiftly resolve project issues.
• Data Integrity & Quality: Review, investigate, and coordinate the resolution of study queries with CRO personnel to maintain the highest standards of data integrity.

What We're Looking For

• Education: Bachelor's degree in Analytical Chemistry, Chemistry, Biochemistry, or a closely related scientific field.
• Experience: 6+ years of relevant industry experience within a pharmaceutical company, biotech, or a CRO with a dedicated focus on bioanalysis oversight.
• Regulatory Rigor: Deep understanding and practical experience working under GLP and GCLP principles and guidelines.
• Technical Proficiency: Hands-on experience or deep oversight familiarity with key bioanalytical techniques, including LC-MS/MS, ELISA, and MSD.
• Team-First Mindset: A proven track record of working effectively within multidisciplinary project teams to drive successful program outcomes.
• Execution Skills: Exceptional attention to detail with the ability to balance and prioritize multiple fast-moving projects simultaneously.
• Communication: Clear, effective verbal and written communication skills to articulate complex scientific data to diverse technical and non-technical stakeholders.