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.
