Senior Scientist, Downstream Process Development (Viral Vector)

Location: United States

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

Company

hirify.global is a biotechnology company providing research and biomanufacturing services, while its ProBio subsidiary operates as a global CDMO 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, and report AAV and LVV purification experiments.
• Evaluate and implement new bioprocessing technologies and strategies with internal and external partners.
• Support technology transfer, cGMP risk evaluation, deviation management, and manufacturing activities with Analytical, Manufacturing, Supply Chain, Facilities, QA, and QC teams.
• Maintain project timelines and present process development and manufacturing updates to project and management teams.
• Prepare CMC sections for IND, annual report, and BLA submissions, as well as invention disclosures, progress reports, and publications.

Requirements

• Master’s or Ph.D. degree with 5+ years of relevant industry experience in chemical or biochemical engineering, biological sciences, or a related discipline.
• Industry experience in biotech development, gene and cell therapy product design, and preferably viral vector process development and manufacturing.
• Strong understanding of process scale-up, scale-down modeling, Design of Experiments, and statistical analysis.
• Ability to work independently in a hands-on laboratory setting and learn new techniques.
• Strong documentation, organizational, communication, prioritization, and teamwork skills.
• Experience with FDA and EMA CMC regulatory affairs is advantageous.

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, life and disability insurance, legal assistance, and supplemental insurance plans.
• Commuter benefits, well-being initiatives, and peer-to-peer recognition programs.