Director of Assay Verification, Validation & Quality Control

SiPhox Health; Burlington (MA); On-site; USD 190,000 - 230,000; Full time

Job summary

SiPhox Health is seeking a Director of Assay Verification, Validation & Quality Control to lead the transition of immunoassays from development into validated, routinely manufactured products. You will own the V&V and QC strategy, oversee analytical performance studies, and drive regulatory-ready documentation in a fast-paced FDA-regulated environment.

The role requires hands-on leadership, strong statistical judgment, and the ability to coordinate across assay development, systems engineering,

Qualifications

• PhD or equivalent with 7+ years in industry; or MS/BS with 10+ years of relevant experience.
• Direct people-management or team-leadership experience (3+ years).
• Experience developing/validating quantitative immunoassays in an FDA-regulated setting.

Responsibilities

• Develop and oversee the assay verification/validation strategy and protocols.
• Lead analytical performance studies and QC/lot-release methods.
• Coordinate cross-functional teams across assay development, manufacturing, clinical, regulatory, software, and quality.
• Establish validated, scalable QC trending and data-review processes.
• Mentor a high-performing team of scientists and technicians.

Skills

Leadership

Statistical judgment

Immunoassay expertise

Data analysis

Regulatory experience

Education

PhD in biochemistry, analytical chemistry, bioengineering, immunology, biomedical engineering, or related

Tools

JMP

Minitab

R

Python

Job description

SiPhox Health is building a new generation of accessible, high-frequency health testing. Our SiPhox One platform combines automated sample processing, immunoassays, microfluidics, and silicon photonics in a compact system designed to bring quantitative laboratory testing closer to the patient. We are developing a prescription-use in vitro diagnostic platform and preparing the product, assays, manufacturing processes, and quality system for analytical and clinical validation and FDA submission.

The Role

SiPhox is seeking a Director of Assay Verification, Validation & Quality Control to lead the transition of our immunoassays from development into validated, routinely manufactured products.

This is a senior, hands-on technical leadership role with responsibility for assay verification and validation strategy, analytical performance studies, quality-control methods, lot-release testing, and ongoing assay performance monitoring. You will build the systems and team required to demonstrate that each assay consistently meets its intended-use requirements across reagent lots, cartridge lots, instruments, operators, sites, and the expected range of specimen and environmental conditions.

The ideal candidate combines deep quantitative immunoassay experience with rigorous study design, strong statistical judgment, practical laboratory leadership, and experience operating within an FDA-regulated IVD environment. You should be equally comfortable writing a validation strategy, reviewing raw data, troubleshooting an unexpected bias, establishing lot-release criteria, and coordinating execution across assay development, systems engineering, manufacturing, clinical, regulatory, software, and quality.

This role owns the technical planning and execution of assay V&V and QC. Quality Assurance retains independent responsibility for quality-system oversight and approval of controlled protocols, deviations, release procedures, and final reports.

What You Will Own

Assay verification and validation

• Develop and maintain the overall assay verification and validation strategy, including study sequencing, resource requirements, sample plans, acceptance criteria, risk controls, and traceability to product requirements.
• Translate intended-use claims and assay performance requirements into statistically sound, executable protocols.
• Lead analytical performance studies, including precision and reproducibility, linearity and measuring interval, analytical sensitivity, LoB/LoD/LoQ, interference, cross-reactivity, high-dose hook effect, method comparison, matrix comparison, specimen stability and handling, calibration and traceability, reference interval verification, carryover, and assay robustness.
• Ensure studies appropriately evaluate relevant reagent lots, cartridge lots, instruments, operators, days, sites, and specimen populations.
• Establish scientifically justified sample sizes, replicate structures, statistical methods, and acceptance criteria using applicable CLSI guidance and FDA expectations.
• Oversee protocol execution, data review, deviation assessment, root-cause investigation, and preparation of clear, submission-ready reports.
• Maintain assay requirements traceability and ensure objective evidence supports each analytical performance claim.
• Identify validation risks early and drive mitigation plans before they affect clinical studies or regulatory submission timelines.

Quality control and lot release

• Design and implement incoming, in-process, and finished-product QC methods for critical assay reagents, controls, calibrators, microprinted sensor chips, and completed cartridges.
• Establish practical, statistically justified lot-release specifications and sampling plans.
• Define the assay-related lot strategy and evaluate the impact of raw-material, antibody, conjugation, surface-chemistry, microprinting, formulation, lyophilization, cartridge, and process changes.
• Lead qualification and lifecycle management of assay controls and calibrators, including target assignment, stability monitoring, bridging, and replacement.
• Establish lot-to-lot comparability and calibration-transfer procedures that support scalable manufacturing.
• Build QC trending and statistical process-control systems capable of detecting drift, shifts, variability, and emerging failure modes before product release.
• Provide technical leadership for assay-related nonconformances, OOS/OOT results, deviations, complaints, CAPAs, and change-control assessments.
• Partner with Manufacturing and Quality to establish efficient release workflows that maintain scientific rigor without creating unnecessary production bottlenecks.

Assay transfer and lifecycle management

• Lead the formal transfer of assays and test methods from assay development into controlled V&V and manufacturing/QC environments.
• Define method suitability, method validation, equipment qualification, analyst training, reference materials, data systems, and documentation required for routine execution.
• Establish clear development-exit criteria so assays enter V&V only when sufficiently mature.
• Work with assay development and systems engineering to investigate failures involving assay chemistry, microfluidics, cartridge mechanics, optics, software algorithms, sample preparation, or instrument behavior.
• Support design changes, supplier changes, process improvements, and post-market assay monitoring through data-driven impact assessments.
• Ensure knowledge gained during validation and routine QC is fed back into assay design, manufacturing controls, risk management, and product specifications.

Team and operational leadership

• Recruit, develop, and lead a high-performing team of assay validation scientists, QC scientists, research associates, and laboratory technicians.
• Build laboratory schedules and capacity plans aligned with manufacturing lots, instrument availability, clinical studies, and regulatory milestones.
• Create clear ownership, training, review, and escalation practices for protocol execution and data integrity.
• Establish a culture of disciplined execution, scientific transparency, careful documentation, and rapid but evidence-based problem solving.
• Manage external laboratories, consultants, clinical sites, reference-method providers, and specialized vendors when appropriate.
• Communicate program status, risks, resource needs, and decisions clearly to technical leadership and the executive team.

What Success Looks Like

Within the first 6 months, you will have:

• Established an integrated assay V&V and QC organization with clear roles, procedures, capacity, and decision rights.
• Converted assay performance requirements into approved, executable analytical validation plans and protocols.
• Implemented robust QC methods and lot-release criteria for critical reagents and finished cartridges.
• Created a scalable system for lot qualification, control and calibrator management, assay trending, and investigation of anomalous results.
• Delivered high-quality analytical study data and reports that withstand internal, external, and regulatory scrutiny.
• Reduced late-stage surprises by identifying assay, lot, instrument, and workflow risks before formal validation execution.
• Built strong working relationships across Assay Development, Engineering, Manufacturing, Clinical, Regulatory, Software, and Quality.

Required Qualifications

• PhD in biochemistry, analytical chemistry, bioengineering, immunology, biomedical engineering, or a related field with at least 7 years of relevant industry experience; or an MS/BS with at least 10 years of relevant experience.
• At least 3 years of direct people-management or substantial technical team-leadership experience.
• Demonstrated experience developing and validating quantitative immunoassays or other quantitative IVD assays.
• Direct experience designing, executing, analyzing, and documenting analytical performance studies for an FDA-regulated diagnostic product.
• Strong knowledge of precision, linearity, detection capability, interference, cross-reactivity, method comparison, stability, and robustness study design.
• Working knowledge of applicable CLSI standards, FDA expectations, design controls, risk management, and regulated documentation practices.
• Experience establishing QC methods, acceptance criteria, lot-release testing, assay trending, and investigation of OOS/OOT results.
• Strong statistical judgment and the ability to distinguish meaningful assay effects from ordinary analytical, biological, lot, and instrument variability.
• Experience with calibration, controls, reference materials, lot bridging, and reagent or assay transfer into manufacturing.
• Excellent technical writing skills, including protocols, reports, investigations, risk assessments, and regulatory-supporting documentation.
• A hands-on leadership style and willingness to work directly with laboratory data, instruments, samples, and cross-functional teams.

Preferred Qualifications

• Experience with 510(k) submissions and FDA interactions for quantitative immunoassays or clinical chemistry products.
• Experience with point-of-care, near-patient, prescription home-use, or highly automated diagnostic systems.
• Experience with multiplex immunoassays, microfluidic cartridges, optical or label-free biosensors, lyophilized reagents, or capillary whole-blood specimens.
• Familiarity with integrated systems that combine sample preparation, fluidics, assay chemistry, optics, algorithms, and software.
• Experience with ISO 13485, 21 CFR Part 820/QMSR, ISO 14971, electronic data systems, and data-integrity controls.
• Experience qualifying external suppliers and managing critical biological reagent changes.
• Experience planning V&V capacity across multiple instruments, reagent lots, cartridge batches, operators, and test sites.
• Familiarity with statistical tools such as JMP, Minitab, R, Python, or equivalent platforms.

Leadership Profile

We are looking for someone who:

• Brings structure and rigor without losing speed or practical judgment.
• Uses data to make decisions and communicates uncertainty directly.
• Understands the difference between an exploratory experiment and objective evidence suitable for a regulated submission.
• Can challenge weak requirements, methods, or acceptance criteria constructively and propose a better path.
• Develops people and systems rather than becoming the sole source of technical judgment.

Works effectively in a fast-moving environment where product, assay, manufacturing, and regulatory constraints must be solved together.

Takes ownership of outcomes and escalates risks early, clearly, and with proposed solutions.

Working Relationships

This role works closely with:

• Assay Development
• Systems, Mechanical, Electrical, Optical, and Software Engineering
• Manufacturing and Supply Chain
• Clinical Operations
• Regulatory Affairs
• Quality Assurance
• Biostatistics and Data Science
• External laboratories, consultants, suppliers, and clinical partners