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.