Senior Validations Specialist

The posting, as Mydnainc wrote it

Our Purpose
Our mission is to build a healthier and more connected world with precision health and genealogy services. We empower individuals with actionable insights into their genetic makeup, fostering a deeper understanding of their ancestry, health, and wellness. By integrating the experience of Gene by Gene Laboratory Services, FamilyTreeDNA genealogy, and myDNA reporting services, we strive to deliver cutting-edge genetic testing and personalized solutions that inspire informed decisions and enhance quality of life. Our team is dedicated to advancing the field of genomics through innovation, research, and a commitment to excellence.

Our Values
All employees are expected to demonstrate our values of Innovate , One Team , and Integrity when carrying out the accountabilities and responsibilities of their role. This is how we show up every day for ourselves, our colleagues and our customers and strategic partners to deliver our vision and strategic goals.

Position Overview
The Senior Validations Specialist is responsible for the analysis and interpretation of genetic data using computational and statistical methods, and for the validation activities that ensure our assays, pipelines, and data systems are accurate, reliable, and ready for use. Working with large-scale genomic data sets, this role identifies patterns and trends, implements quality control measures, and uses a variety of bioinformatics tools - developing new software applications where needed to solve problems in the field of genomics.

As a global company with a presence in the United States, the United Kingdom, and Australia, we operate as lean, hands-on teams where every role has real ownership and visible impact. This position suits someone who moves with urgency, approaches challenges with a solutions-first mindset, and enjoys the pace and variety that come with contributing to moderately complex aspects of projects both independently and collaboratively.

Accountabilities and Responsibilities
Validation and Verification:

• Design, execute, and document validation and verification studies for assays, bioinformatics pipelines, instruments, and data analysis workflows in line with regulatory and accreditation requirements.
• Define acceptance criteria, analyze validation data, and prepare clear, well-organized validation reports documenting the performance metrics of pipelines and products, ensuring that they are in compliance with required quality guidelines.
• Drive validation activities to completion with urgency, proactively removing roadblocks and keeping stakeholders informed of progress and risks.

Bioinformatics Analysis and Interpretation

• Analyze and interpret large-scale biological and genomic data sets using computational and statistical methods.
• Identify patterns, trends, and anomalies in sequencing and genotyping data, and translate findings into actionable recommendations.
• Apply sound statistical rigor to study design, data analysis, and interp

[…]
lopment / Product teams

• IT and Software Engineering

External Stakeholders

• Accreditation and regulatory bodies (e.g., CAP, CLIA) during audits and inspections
• Instrument, reagent, and software vendors
• External collaborators and reference laboratories, as required

Decision Making
Decisions this role makes alone:

• Selection of analytical methods, statistical approaches, and bioinformatics tools for assigned work.
• Design details of validation and verification studies within approved protocols.
• Day-to-day prioritization and sequencing of tasks within assigned projects.
• Identification and escalation of data quality issues and validation risks.

Decisions this role makes under guidance or escalates

• Final acceptance and release of validated assays, pipelines, or systems (with Quality and management).
• Changes to SOPs, validated processes, or regulated workflows.
• Significant tool, software, or infrastructure purchases.
• Project scope, timeline, and resourcing changes.

Why Join Us
At Gene by Gene, you’ll join a mission-driven team advancing the science of genetics and discovery. You’ll have the opportunity to shape meaningful campaigns, tell compelling brand stories, and collaborate with talented professionals who share your passion for creativity, curiosity, and impact.

Comprehensive Benefits

• Medical & Health Savings: Choice of 3 medical tiers generously sponsored by the company, with a monthly $50–$100 employer HSA contribution based on plan type and dependent level.
• 100% Covered Dental & Vision: No premium costs for employees or dependents.
• 401(k) Matching: Generous 50% company match up to 6% of annual base salary.
• Diverse PTO Framework: Structured time off incorporating vacation, sick leave, mental health days, personal days, company holidays, and a flexible floating holiday.
• Income Protection & Family Leave: Full company sponsorship of Short-Term and Long-Term Disability (STD/LTD) alongside Paid Family Leave offerings.