Senior Analytical Transfer Scientist (Cell Therapy)

Location: Bridgewater, New Jersey, United States; Workplace: On-site

Company

hirify.global develops an advanced cell therapy analytical Cell Q platform and supports cell and gene therapy product development.

What you will do

• Lead the transfer, validation, and optimization of analytical methods for cell and gene therapies.
• Support assays covering identity, potency, purity, and safety, including qPCR/ddPCR, flow cytometry, ELISA, cell-based assays, and viral vector quantification.
• Oversee analytical method transfers to internal and external Quality Control laboratories under GMP and regulatory guidelines.
• Execute product characterization, process development, stability, and comparability testing aligned with FDA, EMA, and ICH standards.
• Analyze complex bioanalytical data and prepare technical reports, protocols, and analytical sections for IND, BLA, and MAA submissions.
• Collaborate with Process Development, Manufacturing, Quality Control, R&D, Quality, Regulatory, and Analytical Development teams.

Requirements

• Master’s or Ph.D. in Analytical Chemistry, Biochemistry, Molecular Biology, or a related field.
• 6–14 years of relevant experience in cell and gene therapy.
• Strong experience with qPCR/ddPCR, flow cytometry, ELISA, cell-based potency assays, and viral vector assays such as AAV and lentivirus.
• Experience developing, validating, and transferring methods under GMP conditions for cell and gene therapy products.
• Knowledge of regulatory filing requirements for viral vectors, gene-modified cells, and advanced therapeutic products.
• Proficiency with FlowJo, JMP, and GraphPad Prism, plus experience working in cross-functional, regulatory-driven environments.

Nice to have

• Experience evaluating emerging analytical technologies and tools.
• Self-awareness, integrity, authenticity, and a growth or entrepreneurial mindset.

Culture & Benefits

• Full-time, on-site work in Bridgewater, New Jersey.
• Fast-paced, mission-driven environment.
• Opportunity to contribute to cell therapy analytical platform development as a technical subject matter expert.
• Leveling is based on overall experience, education, and demonstrated knowledge during the interview process.