Sr. Scientist, Reagent Development

Veracyte • South San Francisco, CA

5h • $150,000 - $170,000 • Onsite

About The Position

Veracyte is seeking an experienced Senior Scientist to provide scientific and technical leadership within its Reagent Development team. The role independently leads complex reagent and analytical method development for NGS-based clinical laboratory products, from feasibility and technical strategy through characterization, qualification, transfer, and lifecycle support. The Senior Scientist defines experimental approaches and integrates biochemical, physicochemical, statistical, quality, and operational considerations to make clear technical decisions from incomplete or conflicting data.

The successful candidate combines hands-on scientific expertise with the ability to establish direction, anticipate risk, solve ambiguous cross-disciplinary problems, and guide other individual contributors. The role delivers robust reagent formulations, analytical and QC strategies, data-supported specifications, transferable methods, and complete design-control documentation, while promoting scientific rigor across the team.

This position partners with teams including Molecular Biology, Product Development, Automation, Manufacturing, Quality, Regulatory, Supply Chain, and Clinical Laboratory. The posted salary range is $150,000–$170,000 USD. The role may also be eligible for discretionary bonuses or incentives and restricted stock units.

Requirements

• Ph.D. in Analytical Chemistry, Biochemistry, Chemistry, Molecular Biology, Chemical Engineering, or a related field with 6 or more years of relevant industry experience; alternatively, an M.S. with 7 or more years of relevant industry experience.
• Ability to independently lead complex technical projects, define strategy, plan and execute studies, and drive decisions through implementation.
• Experience guiding scientists, research associates, or other individual contributors through project leadership, mentoring, or matrixed team leadership.
• Experience developing and characterizing chemical or biochemical reagents and developing analytical methods or QC assays, with hands-on experience in NGS, nucleic acid sample preparation, or related molecular diagnostic workflows.
• Success troubleshooting complex, multivariable technical problems and identifying root cause using hypothesis-driven, data-based approaches.
• Experience working under design controls and in an ISO 13485 and/or GMP-regulated environment, including authoring or reviewing controlled technical documentation.
• Proficiency with relevant physicochemical and biochemical methods, potentially including pH, conductivity, osmolality, density, refractive index, viscosity, UV-Vis and fluorescence spectroscopy, Karl Fischer, HPLC/UHPLC, CE-SDS, and DLS/zeta potential.
• Strong working knowledge of statistics and quality science, including DOE, Gage R&R or measurement-system analysis, process capability, SPC, lot-to-lot trending, stability modeling, and specification setting.
• Proficiency with JMP, Minitab, Python, or R.
• Excellent written and verbal communication skills, including the ability to present complex data, risks, trade-offs, and recommendations to varied audiences.

Nice To Haves

• Experience with bead-based reagents, enzymes, surfactants, polymers, or viscous, high-salt, or otherwise challenging formulations.
• Working knowledge of additional characterization techniques such as FTIR/Raman, GPC/SEC, ion chromatography, ICP-OES/MS, GC, DSF/nanoDSF, LC-MS, cIEF, or rheometry.
• Experience with raw-material qualification, supplier technical management, formulation scale-up, stability-study design, method transfer, and manufacturing investigations.
• Experience developing workflows for automation or high-throughput clinical laboratory operations, including liquid handling, throughput, QC, and operational robustness.
• Familiarity with CLIA/CAP laboratory environments and development of reagents or assays for clinical, diagnostic, or other regulated applications.

Responsibilities

• Independently lead complex reagent-development projects from concept through implementation, owning technical strategy, objectives, study design, execution, analysis, risk management, documentation, and delivery against milestones.
• Translate product, assay, manufacturing, quality, and business needs into practical development plans, technical requirements, decision criteria, and stage-appropriate deliverables.
• Analyze and interpret complex datasets, identify critical-path activities and risks, adjust plans proactively, and escalate issues with options and recommended actions.
• Provide technical direction to scientists and associates by defining expectations, reviewing plans and data, monitoring progress, and helping resolve roadblocks.
• Develop, optimize, and characterize buffers, enzyme formulations, bead-based reagents, and other multicomponent solutions used in NGS and nucleic acid sample-preparation workflows.
• Determine how raw-material attributes, formulation composition, processing, packaging, storage, and shipping affect reagent stability, manufacturability, and assay performance.
• Define critical quality attributes and fit-for-purpose analytical strategies for raw materials, intermediates, bulk formulations, and finished reagents.
• Evaluate new analytical and formulation approaches to improve reagent performance, robustness, scalability, stability, and operational readiness.
• Integrate physicochemical, biochemical, and functional data to relate reagent attributes to NGS performance.
• Lead development, qualification, and transfer of analytical and functional QC methods for incoming materials, in-process samples, bulk formulations, and finished reagents.
• Define controls, reference materials, sampling strategies, measurement requirements, and statistically justified acceptance criteria.
• Identify sensitive, precise, and practical analytical measurements and surrogate functional assays to predict performance and support process-control or release decisions.
• Lead investigations into out-of-specification, out-of-trend, stability, lot-to-lot, and performance issues; determine root cause, assess impact, and recommend corrective or preventive actions.
• Establish performance-trending approaches and use data to identify risks and continuous-improvement opportunities.
• Apply DOE, measurement-system analysis, risk-based experimentation, process capability, SPC, stability modeling, and other statistical tools to optimize formulations and methods and reduce variability.
• Lead or make substantial technical contributions to design inputs and outputs, requirements, FMEA and other risk assessments, verification and validation strategies, protocols, reports, and design reviews.
• Author and critically review SOPs, test methods, specifications, protocols, technical reports, and investigation records for scientific rigor, traceability, and review readiness.
• Ensure development work and documentation comply with applicable design-control, ISO 13485, GMP, and internal quality-system expectations.
• Lead transfer of formulations, analytical methods, and QC assays into Manufacturing and Quality Control, including planning, readiness assessment, training, comparability studies, and resolution of transfer issues.
• Provide scientific leadership for raw-material qualification, supplier evaluation, supplier-documentation assessment, and changes to materials, processes, methods, or specifications.
• Partner with cross-functional teams to align technical decisions with product and operational needs.
• Communicate complex data, uncertainty, risk, and recommendations to technical contributors, cross-functional partners, and leadership.
• Mentor and develop junior scientists and associates through experimental guidance, technical review, feedback, and strong examples of scientific reasoning and documentation.

Benefits

• Competitive compensation and benefits.
• The role may be eligible for additional discretionary bonuses or incentives and restricted stock units.
• Inclusive workforce and workplace commitments, with diverse backgrounds represented, engaged, and empowered to drive innovative ideas and decisions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree