Senior Scientist, Analytical Development (FFBA)

Location: Onsite in Somerset, New Jersey, United States. Applicants must be authorized to work in the United States and complete Form I-9 and E-Verify employment verification.

Base pay: $127,313–$167,099 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, and NK cell-based treatments.

What you will do

• Develop, optimize, qualify, and execute analytical methods for cell and gene therapy product release and characterization.
• Establish assays including flow cytometry, cell-based potency and functional assays, immunoassays, infectious titer assays, particle size, and compendial methods.
• Lead assay technology transfers between collaborators, Analytical Development, Quality Control, and external partners.
• Define critical assay parameters, reagents, materials, and specifications, including qualification of cell banks.
• Author and review analytical methods, SOPs, protocols, reports, laboratory records, and QC documentation.
• Collaborate with QC, Process Development, and Manufacturing teams while mentoring junior scientists and presenting scientific data.

Requirements

• PhD with 5–8 years of experience or Master’s degree with 8–10 years of experience in analytical development or QC for gene-modified products in biotechnology or pharmaceutical settings.
• Advanced expertise in analytical method development, qualification, and validation for vaccines, biologics, viral vectors, or cell and gene therapies.
• Experience with lentiviral vector characterization, multicolor flow cytometry, reporter gene cell lines, potency, cytotoxicity, cytokine release, immunoassay, and infectious titer methods.
• Knowledge of ICH guidelines, regulatory expectations, analytical comparability, method bridging, technology transfer, data trending, and critical material qualification.
• Ability to lead, mentor, and develop junior staff; make independent scientific decisions; and communicate through technical writing and presentations.
• Strong written and verbal English skills and authorization to work in the United States are required.

Nice to have

• Experience with late-stage analytical validation, IND/BLA preparation, and global development programs.
• Experience with HPLC, pH, osmolality, particulate matter, and other compendial methods.
• Technical training or certification and Mandarin language skills.

Culture & Benefits

• Permanent full-time employees receive medical, dental, and vision insurance.
• Benefits include a 401(k) plan with company match, paid parental leave, paid time off, and company holidays.
• Additional offerings include flexible spending and health savings accounts, disability coverage, life insurance, commuter benefits, and family care resources.
• Contractors are not eligible for benefits through hirify.global.