Associate Director, Quality Control- Analytical Tech Services (Biotech)

Location: Frederick, Maryland, United States

Salary: $165,495–$214,170 per year, plus potential annual bonus, stock-based long-term incentives, paid time off, and benefits.

Company

hirify.global is a biopharmaceutical company developing cancer immunotherapies, including CAR-T and TCR-engineered cell therapies.

What you will do

• Lead the Quality Control Analytical Tech Services group supporting commercial CAR-T operations.
• Provide technical support for qPCR/ddPCR, flow cytometry, cell-based bioassays, and analytical assay automation.
• Lead method development, validation, transfers, process trending, procedural updates, and continuous improvement.
• Support laboratory investigations, deviations, CAPAs, change controls, inspection readiness, audits, and regulatory inspections.
• Establish data analytics and metrics for monitoring method, product, and invalid trends.
• Supervise, train, and mentor junior staff while collaborating with Quality Assurance, Analytical Development, Manufacturing, Material Management, Regulatory, and Supply Chain teams.

Requirements

• Advanced scientific degree with 2+ years of relevant experience, or a master’s degree with 8+ years, a bachelor’s degree with 10+ years, or a high school degree with 14+ years in biologics or cell-gene therapy QC Analytical or Analytical Development.
• Experience with bioanalytical methods in GMP conditions and QC laboratory quality systems.
• Experience conducting investigations, writing deviations, implementing CAPA, and initiating change controls.
• Knowledge of GMP, GLP, Quality Control, and regulatory requirements including 21 CFR Parts 11, 210, and 211.
• Experience supervising or managing analytical laboratories in biotechnology or pharmaceutical environments.
• Strong collaboration, communication, negotiation, and team-development skills.

Nice to have

• Experience applying GMP requirements across US, EU, and Rest-of-World standards.
• Experience with LIMS development and integration, equipment and software lifecycle processes, and technology implementation.
• Experience working in a fast-paced small-company environment with changing priorities and minimal direction.

Culture & Benefits

• Work focused on developing cancer immunotherapies and advancing personalized CAR-T treatments.
• Medical, dental, vision, and life insurance plans for eligible employees.
• Paid time off and potential discretionary annual bonus and stock-based long-term incentives.
• Inclusive work environment focused on employee development, collaboration, and diverse perspectives.