Scientist II, Bioanalytical Assay Development

Scientist I/II, Bioanalytical Assay Development

South San Francisco, CA

Our client is an emerging gene therapy biotech developing next‑generation therapeutics using cutting‑edge gene engineering platforms. The company is advancing a pipeline of preclinical and early clinical programs targeting serious unmet medical needs.

We are hiring a Scientist who will work on the bioanalytical strategy across preclinical and clinical programs, from assay design through regulatory submission support. You will support development, qualification, and validation of PK/PD, biomarker, and potency assays, manage external partners, and serve as a key interface between Research, Development, and Regulatory to drive data‑driven decisions.

Responsibilities

• Design, develop, and execute bioanalytical assays to support preclinical and clinical studies, including PK/PD and biomarker assessments
• Perform routine and complex experiments, analyze data, and clearly document results
• Support development of cell-based potency assays for early-stage and clinical programs
• Troubleshoot assays and optimize methods to improve performance and reproducibility
• Maintain accurate and organized laboratory records and ensure data integrity
• Collaborate with cross-functional teams including R&D, Clinical Development, and Translational Sciences
• Coordinate with external CROs for sample analysis and timelines as needed
• Contribute to regulatory documentation by supporting bioanalytical sections of INDs and other filings
• Stay current with relevant technologies and apply new methods where appropriate
• Present findings in team meetings and contribute to scientific discussions
• Ensure compliance with GLP/GCP standards and internal quality systems

Qualifications

• Ph.D. in Biology, Pharmacology, Bioanalytical Chemistry, or related discipline with 0-5 years of industry experience.
• Demonstrated expertise in development, qualification, and validation of bioanalytical, biomarker, and cell‑based potency assays to support preclinical and clinical studies.
• Deep, hands‑on experience with techniques such as qPCR, digital PCR, ligand‑binding assays (e.g., ELISA, MSD), LC‑MS/MS, flow cytometry, and reporter gene assays.
• Strong understanding of PK/PD concepts, translational science, and how bioanalytical data informs dose selection and clinical strategy.
• Proven track record leading bioanalytical workstreams and driving cross‑functional alignment in a fast‑paced biotech environment.
• Experience managing CROs and external partners, including assay transfer, validation oversight, and routine sample testing.
• Familiarity with regulatory expectations and guidance for bioanalytical methods and data in submissions to agencies such as FDA and EMA.
• Excellent communication, leadership, and organizational skills, with the ability to operate strategically while remaining hands‑on as needed.