Director, Reagent Development (NGS)

TL;DR

Director, Reagent Development (NGS): Leading a team of scientists in the design, development, and optimization of NGS reagents for clinical laboratory products with an accent on biochemistry, molecular biology, and rigorous quality standards. Focus on guiding projects from proof-of-concept through internal implementation while ensuring strict adherence to GMP and ISO 13485 compliance.

Location: Must be based in South San Francisco, California, United States (Onsite)

Salary: $216,000 – $240,000 USD

Company

hirify.global is a global diagnostics company transforming cancer care through genomic insights, advanced bioinformatics, and AI-driven diagnostic platforms.

What you will do

• Direct and mentor a team of R&D scientists to foster innovation and scientific rigor.
• Manage project goals, resource allocation, and timelines for assay and reagent development.
• Lead end-to-end development of enzymes, buffers, and chemical reagents for NGS applications.
• Design and execute verification and validation (V&V) studies for manufacturing workflows.
• Ensure all activities comply with ISO 13485, GMP, and internal Quality Management Systems.
• Partner with cross-functional teams to ensure seamless design transfer and scale-up.

Requirements

• Ph.D. in Biochemistry, Molecular Biology, Chemistry, or related discipline.
• 10+ years of industry experience with 5+ years in a leadership role.
• Extensive hands-on experience developing reagents or kits for NGS.
• Proven track record in GMP/ISO 13485 regulated environments.
• Familiarity with CLIA/CAP guidelines for clinical laboratory standards.
• Must be able to work onsite in South San Francisco, CA.

Nice to have

• Expertise in Design of Experiments (DoE) and statistical analysis.
• Experience managing raw material supply chains and external vendor interactions.

Culture & Benefits

• Purpose-driven environment focused on transforming cancer care.
• Competitive compensation package including discretionary bonuses and restricted stock units.
• Commitment to an inclusive, diverse, and empowering workplace.
• Recognized as a 2024 Certified Great Place to Work.