Sr. Scientist, Reagent Development

Responsibilities

Technical and Project Leadership

• Independently lead complex reagent-development projects from concept through implementation, with ownership of technical strategy, objectives, study design, execution, analysis, risk management, documentation, and delivery against program milestones.
• Translate product, assay, manufacturing, quality, and business needs into practical reagent-development plans, technical requirements, decision criteria, and stage-appropriate deliverables.
• Independently analyze and interpret complex datasets.
• Identify critical path activities, dependencies, resource needs, and emerging risks; adjust plans proactively and escalate issues with clear options and recommended actions.
• Provide technical direction to scientists and associates contributing to project work.

Formulation, Characterization, and Analytical Strategy

• Lead the development, optimization, and characterization of buffers, enzyme formulations, bead-based reagents, and other multicomponent solutions used in NGS and nucleic acid sample-preparation workflows.
• Develop a mechanistic understanding of how raw-material attributes, formulation composition, processing conditions, packaging, storage, and shipping affect reagent stability, manufacturability, and downstream assay performance.
• Define critical quality attributes and build fit-for-purpose analytical strategies for raw materials, intermediates, bulk formulations, and finished reagents.
• Conceive and evaluate innovative analytical or formulation approaches to improve reagent performance, robustness, scalability, stability, and operational readiness.
• Integrate orthogonal physicochemical, biochemical, and functional data to establish meaningful relationships between reagent attributes and NGS performance.

QC Assay Development and Lifecycle Support

• Lead the 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 appropriate to intended use and development stage.
• Identify analytical measurements and surrogate functional assays that are sufficiently sensitive, precise, and practical to predict performance and support in-process control or release decisions.
• Lead investigations of out-of-specification, out-of-trend, stability, lot-to-lot, and performance issues; determine root cause, assess impact, and recommend scientifically justified corrective or preventive actions.
• Establish approaches for trending reagent, method, and process performance and use the resulting data to identify risk and continuous-improvement opportunities.

Statistics, Quality, and Design Control

• Apply DOE, measurement-system analysis, risk-based experimentation, process capability, SPC, stability modeling, and other statistical tools to optimize formulations and methods, quantify uncertainty, 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 within the quality management system.
• Author and critically review SOPs, test methods, specifications, protocols, technical reports, and investigation records for scientific rigor, traceability, and readiness for cross-functional or quality review.
• Ensure development work is performed and documented in accordance with applicable design-control, ISO 13485, GMP, and internal quality-system expectations.

Technology Transfer and Cross-Functional Leadership

• Lead transfer of formulations, analytical methods, and QC assays into Manufacturing and Quality Control, including transfer planning, readiness assessment, training, comparability studies, and resolution of transfer-related issues.
• Provide scientific leadership for raw-material qualification, supplier evaluation, technical assessment of supplier documentation, and changes to materials, processes, methods, or specifications.
• Partner effectively with Molecular Biology, Product Development, Automation, Manufacturing, Quality, Regulatory, Supply Chain, and Clinical Laboratory teams to align technical decisions with product and operational needs.
• Communicate complex data, uncertainty, risk, and recommendations clearly to technical contributors, cross-functional partners, and leadership.
• Mentor and develop junior scientists and associates through experimental guidance, technical review, constructive feedback, and modeling of high standards for scientific reasoning and documentation.

Required Qualifications

• PhD. in Analytical Chemistry, Biochemistry, Chemistry, Molecular Biology, Chemical Engineering, or a related field with 6+ years of relevant industry experience, or an M.S. with 7+ years of relevant industry experience.
• Proven ability to independently lead complex technical projects, including defining strategy, planning and executing studies, and driving decisions through implementation.
• Demonstrated experience guiding the technical work of 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.
• Demonstrated success troubleshooting complex, multivariable technical problems and identifying root cause using hypothesis-driven, data-based approaches.
• Experience working under design controls and within an ISO 13485 and/or GMP-regulated environment, including authorship or review of controlled technical documentation.
• Proficiency with relevant physicochemical and biochemical methods, which may include 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.

Preferred Qualifications

• 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 consideration of 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.