Scientist I, Analytical Development (Cell Therapy)

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

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

Company

Global biotechnology organization developing cell and gene therapies, including CAR-T, TCR-T, NK-cell, and other immunotherapy platforms.

What you will do

• Develop, optimize, qualify, and execute analytical methods for viral vector and CAR-T product characterization, release, stability, titer, particle size, flow cytometry, and cell-based potency.
• Perform pre-qualification, assay qualification, product release, and characterization testing in a regulated quality control environment.
• Author and review methods, protocols, reports, SOPs, and related controlled documents.
• Transfer analytical methods to quality control and external collaborators, and support incoming method transfers.
• Maintain accurate electronic laboratory records, instrument maintenance records, sample inventories, and reagent supplies in accordance with ALCOA+ standards.
• Collaborate with process development, quality control, and manufacturing teams on assay execution, troubleshooting, data integrity, and continuous improvement.

Requirements

• Bachelor’s degree with 5+ years of relevant experience, Master’s degree with 3–5 years, or 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.
• Understanding of ICH guidelines, regulatory expectations, assay qualification, release testing, and product characterization in regulated environments.
• Strong written and verbal English communication skills.
• Experience with analytical and laboratory tools such as GraphPad Prism, Power BI, R, FlowJo, CytoExpert, FCS Express, NovoExpress, ELN, and LabVantage.

Nice to have

• Experience implementing or executing compendial methods.
• Experience with document change management and review or approval workflows.
• Mandarin language skills.

Culture & Benefits

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