Manager, Quality Control Bioassay

Location: San Diego, California, United States; full-time, in-person presence required

Company

hirify.global is a global biopharmaceutical company developing medicines for patients with serious and rare diseases.

What you will do

• Oversee cell-based biological potency, protein chemistry, and molecular biology assays in a GMP environment.
• Manage routine QC testing, data review, summary reports, assay transfers, qualifications, and validations.
• Supervise direct reports and establish the QC laboratory, including equipment calibration and reagent tracking.
• Act as a subject matter expert for CDMO method transfer and testing activities.
• Author and review analytical SOPs, protocols, and reports, and represent the analytical laboratory on CMC teams.
• Manage deviations, CAPA, change controls, OOS/OOT investigations, LIMS workflows, and assay control charts.

Requirements

• Bachelor’s degree with at least 7 years of relevant industry experience, or a master’s degree with at least 5 years of relevant industry experience.
• Pharmaceutical industry experience with a GMP testing focus, preferably across the analytical method and testing lifecycle.
• Experience with cell-based potency assays, molecular biology assays, and protein chemistry assays.
• Experience with related instrumentation and software, including JESS, droplet digital PCR systems, cell counters, and PLA.
• Significant experience working in an FDA-regulated environment.
• Full-time, in-person work in the San Diego office is required.

Nice to have

• Experience with JMP statistical software.

Culture & Benefits

• Medical, dental, vision, and mental health coverage.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible schedules with purposeful in-person collaboration.
• 401(k) plan with company match, annual equity awards, employee stock purchase plan, and company-paid life and disability insurance.
• Learning programs, mentorship, networking opportunities, employee resource groups, and service programs.
• Minimal travel expected.