Quality Control Analyst (Biotech)

Location: On-site in Bridgewater, New Jersey, United States; must be able to commute to Bridgewater

Salary: $90,000–$210,000 per year

Company

hirify.global develops integrated technologies and operates Smart Factories for automated, large-scale cell therapy manufacturing.

What you will do

• Perform routine and non-routine analytical, biochemical, and biological QC testing for in-process materials, raw materials, finished goods, and stability samples.
• Execute cell therapy assays including dPCR, qPCR, cell-based potency, proliferation, ELISA, and multicolor flow cytometry testing.
• Review analytical results, prepare COA/COT documents, and compile data for accuracy and regulatory compliance.
• Investigate OOS/OOT results, quality control deviations, and support CAPA, change control, audits, and quality metrics.
• Support method development, validation, technical transfer, equipment validation, calibration, maintenance, and troubleshooting.
• Write and revise test methods, protocols, reports, SOPs, and stability documentation.

Requirements

• Bachelor's degree in a science discipline or comparable experience.
• 2+ years of operational cGMP or cGxP experience supporting manufacturing in a pharmaceutical or biotech environment is preferred.
• Experience with method development and validation.
• Experience with immune cell phenotyping by multicolor flow cytometry, dPCR, qPCR, cell-based potency, or related cell therapy assays is preferred.
• Knowledge of pharmaceutical cGMP requirements in the US and EU is preferred.
• Must be able to commute to Bridgewater, New Jersey.

Culture & Benefits

• Fast-paced, mission-driven environment focused on scaling access to cell therapies.
• Medical, dental, and vision plans with substantial employer subsidy.
• 401(k) matching, on-site lunches, and stock options.
• Leveling is based on experience, education, and demonstrated knowledge during interviews.