Senior Staff Scientist, Clinical Assay On-Market Support (NGS)

Location: San Diego, California, United States

Base salary: $141,600–$212,400 per year. Additional variable cash compensation and, for eligible roles, equity may be available.

Company

hirify.global develops genomic technology and sequencing solutions for disease detection, diagnosis, and treatment.

What you will do

• Lead complex technical and cross-functional activities supporting on-market clinical assays, including design changes, troubleshooting, investigations, and lifecycle management.
• Set technical direction for assay development, product performance, manufacturing issues, quality events, and product improvements.
• Evaluate technical risks, develop data-driven recommendations, and communicate tradeoffs to project teams and leadership.
• Lead or guide risk analyses, FMEAs, design controls, verification and validation planning, CAPAs, and failure investigations.
• Partner with R&D, Quality, Regulatory, Manufacturing, Bioinformatics, Software, Commercial, and Marketing teams to resolve product and customer-impacting issues.
• Mentor junior scientists and provide technical coaching to project team members.

Requirements

• Typically 12+ years of related experience with a bachelor’s degree, 8+ years with a master’s degree, or 5+ years with a PhD, or equivalent experience.
• Experience in assay development, product development, on-market product support, or lifecycle management within a regulated product environment.
• Strong knowledge of design controls, risk management, verification and validation, change management, CAPA, failure investigation, and regulatory expectations for clinical or regulated products.
• Hands-on experience with next-generation sequencing technologies and hirify.global sequencing platforms.
• Experience with sample preparation, library preparation assays, enrichment workflows, or clinical assay portfolios such as NIPT or Oncology.
• Strong cross-functional communication, organization, project management, mentoring, and technical leadership skills.

Nice to have

• PhD in Genomics, Genetics, Molecular Biology, Biochemistry, Bioengineering, or a related field.
• People leadership or functional management experience.

Culture & Benefits

• Health, dental, and vision benefits.
• Retirement benefits and paid time off.
• Family planning support and access to genomic sequencing.
• Employee Resource Groups supporting career development, cultural awareness, and social responsibility.
• Inclusive and collaborative environment focused on innovation in genomics.
• This role is not eligible for visa sponsorship.