Scientist I, Analytical Development (Cell and Gene Therapy)

Location: Onsite in Somerset, New Jersey, United States. Applicants must be authorized to work in the United States.

Salary: $96,267–$126,351 USD per year, plus performance-based bonus and/or equity for eligible roles.

Company

hirify.global is a biotechnology company developing cell and gene therapies, including CAR-T, TCR-T, NK cell-based therapies, and viral-vector platforms.

What you will do

• Develop, optimize, qualify, and execute analytical methods for viral vectors and CAR-T products, including compendial methods, titer, particle size, flow cytometry, immunoassays, and cell-based potency assays.
• Perform pre-qualification, assay qualification, product release, stability, and characterization testing in a regulated quality control environment.
• Author and review methods, protocols, reports, SOPs, and procedures.
• Transfer methods to QC and external collaborators and receive methods from internal and external partners.
• Maintain electronic laboratory records, instrument maintenance records, sample inventories, and reagent supplies according to ALCOA+ standards.
• Collaborate with process development, QC, and manufacturing teams on assay execution, troubleshooting, data integrity, and continuous improvement.

Requirements

• Bachelor’s degree in a related field with 5+ years of relevant experience, or a master’s degree with 3–5 years, or a PhD with 0–2 years.
• Strong laboratory experience developing flow cytometry, mammalian cell culture, ELISA, and cell-based assays.
• Experience with lentiviral vector characterization, including infectious titer, potency, and transduction efficacy assays.
• Knowledge of ICH guidelines, regulatory expectations, assay qualification, release testing, and product characterization in regulated environments.
• Experience with data analysis and laboratory tools such as GraphPad Prism, Power BI, JMP, R, FlowJo, CytoExpert, FCS Express, NovoExpress, ELN, and LabVantage.
• Strong written and verbal English skills are required. Mandarin is preferred.

Nice to have

• Experience implementing or executing compendial methods.
• Experience with document change management and review or approval workflows.
• Experience authoring SOPs and procedures for established methods.

Culture & Benefits

• Permanent full-time employment with medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that fully vests on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid vacation, personal time, sick time, floating holidays, and eleven company holidays.
• Additional benefits include flexible spending and health savings accounts, disability coverage, commuter benefits, family planning resources, and well-being programs.