Senior Scientist, Downstream Process Development (Gene Therapy)

Location: United States

Company

hirify.global is a biotechnology company providing research and development services and products for healthcare and biotech applications. ProBio, a hirify.global subsidiary, is a global CDMO offering end-to-end 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, chromatography, viral clearance, and sterile filtration.
• Plan and execute AAV and LVV purification experiments, then analyze, interpret, and report the results.
• Evaluate and implement new bioprocessing technologies with internal and external partners.
• Support technology transfer, cGMP risk evaluation, and deviation management with analytical, manufacturing, supply chain, facilities, QA, and QC teams.
• Prepare CMC sections for IND, annual report, and BLA submissions, as well as invention disclosures, progress reports, and publications.
• Present project updates to project and upper management teams while maintaining detailed timelines and documentation.

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 biotech development, preferably involving viral vector process development and manufacturing.
• Strong understanding of process scale-up and scale-down modeling, Design of Experiments, and statistical analysis.
• Experience with gene and cell therapy product design; AAV and LVV process development experience is advantageous.
• Ability to work independently in a hands-on laboratory setting with strong organization, documentation, communication, and collaboration skills.
• Knowledge of CMC regulatory affairs for FDA and EMA submissions is advantageous.

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that fully vests on day one.
• Paid parental leave after three months of employment.
• Paid vacation, personal, sick, floating holiday, and company holiday time.
• Flexible spending and health savings accounts, life and disability insurance, legal assistance, and supplemental insurance plans.
• Commuter benefits, well-being initiatives, and peer-to-peer recognition programs.