Senior Director, Assay V&V & QC

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 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,