Senior Scientist, Downstream Process Development (Gene Therapy)

Location: Piscataway, New Jersey, United States

Salary: $100,000–$130,000 annually, based on skills and experience.

Company

hirify.global is a biotechnology company providing research and development services and products, while its ProBio subsidiary delivers end-to-end CDMO services for plasmids, antibodies, and cell and gene therapies.

What you will do

• Develop and optimize downstream unit operations for viral vector manufacturing, including TFF, affinity, ion-exchange and multimodal chromatography, viral clearance, and sterile filtration.
• Plan, execute, analyze, interpret, and report AAV and LVV purification experiments.
• Support process scale-up, scale-down modeling, technology transfer, GMP risk evaluation, and deviation management.
• Collaborate with analytical, manufacturing, supply chain, facilities, QA, QC, and external partner teams.
• Prepare CMC sections for INDs, annual reports, and BLAs, as well as invention disclosures, progress reports, and publications.
• Present process development and manufacturing support updates to project and management teams.

Requirements

• Master’s or Ph.D. degree in Chemical or Biochemical Engineering, Biological Sciences, or a related scientific discipline.
• 5+ years of relevant industry experience in biotechnology development, particularly gene and cell therapy product design.
• Experience in viral vector process development and manufacturing, with strong understanding of process scale-up and scale-down modeling.
• Good understanding of Design of Experiments and statistical analysis.
• Strong organizational, documentation, communication, prioritization, and teamwork skills.
• Ability to work independently in a hands-on laboratory setting and support GMP-compliant manufacturing activities.

Nice to have

• Experience with LVV and AAV process development.
• Experience with CMC regulatory affairs for the FDA and EMA.

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match fully vested from the first day.
• Paid parental leave after three months of employment.
• Paid vacation, personal, sick, floating holiday, and company holiday time.
• Flexible spending and health savings accounts, disability coverage, life insurance, commuter benefits, and well-being programs.