Principal Scientist, Bioanalytical Lead (South San Francisco)

Principal Scientist, Bioanalytical Lead

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 Principal Scientist who will own the bioanalytical strategy across preclinical and clinical programs, from assay design through regulatory submission support. You will lead 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

• Lead design, development, qualification, and validation of bioanalytical assays to support preclinical and clinical studies, including PK/PD and biomarker assessments for gene and cell therapy programs.
• Develop and implement integrated bioanalytical strategies aligned with overall program plans, regulatory expectations, and translational objectives.
• Oversee sample testing strategy, bioanalysis execution, data review, and interpretation to generate high‑quality, decision‑enabling data.
• Drive development and optimization of cell‑based potency assays to support clinical programs and early indication selection.
• Troubleshoot complex assay and instrumentation issues, improve assay robustness, and ensure operational efficiency and data integrity in the lab and at CROs.
• Contribute to technology assessment and implementation of innovative bioanalytical platforms (e.g., advanced PCR, high‑parameter flow, LC‑MS/MS) within the department.
• Partner cross‑functionally with Research, Translational, Clinical, and Regulatory to integrate bioanalytical readouts into program strategy and clinical development plans.
• Select, qualify, and manage CROs and external vendors, including scope definition, timelines, quality oversight, and issue resolution.
• Author and review bioanalytical content for regulatory submissions (e.g., INDs, CTAs, amendments, responses to health authority questions).
• Present bioanalytical strategies, study designs, and data packages to internal leadership and external collaborators in a clear and compelling manner.
• Ensure adherence to GLP/GCP and internal quality systems, including SOP development, data review, and inspection readiness.
• Mentor, coach, and develop junior scientists and research associates, fostering a collaborative, high‑performance team culture.

Qualifications

• Ph.D. in Biology, Pharmacology, Bioanalytical Chemistry, or related discipline with 8+ years of relevant industry experience (12+ years for Masters).
• 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.