Senior Manager, Development and Design Transfer (NGS)

Location: Austin, TX, United States

Salary: $143,100–$178,900 USD annually

Company

hirify.global develops cell-free DNA testing and personalized genetic diagnostics for oncology, women’s health, and organ health.

What you will do

• Plan, execute, document, and coordinate design transfer activities for next-generation sequencing IVD/PMA assays from late-stage development through launch.
• Lead assay test method development, characterization, analytical validation, process validation, and specification-setting using statistical analysis.
• Manage a multidisciplinary team of scientists conducting QC method development, verification studies, and assay validation.
• Coordinate design transfer from R&D to manufacturing, including operational knowledge transfer, staff training, supply-chain setup, and process improvements.
• Partner with Operations, R&D, Product Management, Quality Assurance, Regulatory Affairs, bioinformatics, and statistics teams.
• Oversee SOPs, work instructions, protocols, reports, regulatory documentation, risk management, and audit-ready records.

Requirements

• Advanced degree in molecular biology or a related discipline; a PhD is preferred, while a Master’s or Bachelor’s degree with equivalent industry experience is considered.
• 6–8 years of post-PhD biotech industry experience or more than 10 years of post-BS/MS biotech experience.
• At least 4 years of experience managing scientists and research associates.
• Hands-on experience with next-generation sequencing and DNA/RNA molecular biology.
• Proven successful design transfer experience for assays and medical devices, including process validation for single-site oncology assays.
• Strong understanding of assay development, design control, analytical validation, manufacturing workflows, and quality and regulatory standards including FDA, ISO, and CLSI.
• In-depth knowledge of GLP/GMP guidelines and experience establishing and following SOPs.
• Proficiency in experimental design, statistical data analysis, DOE, Cpk analysis, Gage R&R, and technical problem-solving.
• Ability to lead multidisciplinary teams, mentor scientists, manage projects, communicate effectively, and report to senior leadership.

Nice to have

• Experience authoring study plans, protocols, and study reports.

Culture & Benefits

• Full-time employment in an inclusive workplace focused on collaboration, accountability, safety, compliance, and continuous learning.
• Medical, dental, vision, life, and disability benefits for eligible employees and dependents.
• Free testing for employees and immediate family members, fertility care benefits, pregnancy and baby bonding leave, 401(k), and commuter benefits.
• Work alongside statisticians, geneticists, physicians, laboratory scientists, software engineers, and other specialists in genetic diagnostics.