Scientist II, Analytical Development (Gene Editing)

TL;DR

Scientist II, Analytical Development (Gene Editing): Developing and qualifying molecular biology methods for the characterization and QC testing of gene and cellular therapy products with an accent on qPCR, ddPCR, and cell-based assays. Focus on ensuring GMP compliance, supporting IND products, and managing analytical method transfers within a fast-paced laboratory environment.

Location: Must be based in Somerset, New Jersey, United States (Onsite)

Salary: $110,706–$145,303 USD

Company

hirify.global is a global biotechnology company dedicated to developing advanced cell therapies, including CAR-T and NK cell-based immunotherapies, to treat life-threatening diseases.

What you will do

• Develop, optimize, and qualify molecular biology methods including VCN, gene editing proficiency, and residual DNA testing.
• Perform routine QC testing for final product, stability, and in-process samples under GMP conditions.
• Review and verify testing data, including data packets and COA documentation.
• Author and revise technical documents such as test methods, SOPs, and trend reports.
• Manage laboratory equipment maintenance, calibration, and inventory.
• Train team members on QC test methods and laboratory procedures.

Requirements

• BS, MS, or Ph.D. in Molecular Biology, Cell Biology, Biochemistry, or related field.
• Significant practical experience in QC testing and method development for gene/cell therapy or biologics.
• Demonstrated expertise in qPCR, ddPCR, ELISA, and cell-based assays.
• Strong understanding of Global Regulatory and cGMP requirements.
• Ability to work onsite in Somerset, NJ.

Nice to have

• Expertise in analytical method qualification, validation, and tech transfer.
• Proficiency in Mandarin.
• Experience with LIMS, ELN, Veeva, GraphPad Prism, and JMP.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan with company match vesting on day one.
• Eight weeks of paid parental leave after three months of employment.
• Generous paid time off policy including vacation, sick time, and eleven company holidays.
• Access to well-being initiatives, family planning resources, and voluntary commuter benefits.