BioProcess Engineer II, Upstream (Gene Therapy)

Location: On site in Louisville, Colorado, United States. Monday–Friday during standard business hours, with occasional off-hours, weekend work, extended manufacturing runs, and approximately 10% travel.

Annual base pay: $99,100–$109,000, plus eligibility for a discretionary bonus and equity award.

Company

hirify.global is a publicly traded biotechnology company developing immunotherapies, cell therapies, vaccines, and gene therapy products for cancer and infectious diseases.

What you will do

• Own upstream viral vector unit operations from cell bank thaw and seed train expansion through cell culture, transfection or infection, vector production, and harvest.
• Design and execute process development and DOE experiments to improve cell growth, productivity, vector titer, and product quality.
• Lead process scale-up from bench equipment to pilot and cGMP manufacturing scale, including single-use stirred-tank bioreactors up to 200 L.
• Develop and qualify scale-down models for troubleshooting, process characterization, and robustness studies.
• Support technology transfer, manufacturing operations, equipment qualification, validation, investigations, and corrective and preventive actions.
• Draft and review batch records, SOPs, qualification protocols, technical reports, and investigation documents; train manufacturing personnel and less experienced colleagues.

Requirements

• Bachelor’s degree in Chemical Engineering, Bioengineering, Biotechnology, or a related field with 5+ years of relevant experience, or a master’s degree with 3+ years of experience.
• Hands-on experience in viral vector purification for gene therapy, upstream cell culture, bioreactor operation, process scale-up, and scale-down model development.
• Strong knowledge of mammalian cell culture, media and feed optimization, cell banking, seed train expansion, bioreactor engineering, mass transfer, mixing, gassing, and single-use systems.
• Experience with cGMP aseptic manufacturing, upstream harvest operations, in-process analytics, technical GMP documentation, and applicable FDA, ICH, and USP guidance.
• Ability to work in laboratories, manufacturing areas, warehouses, and classified cleanrooms; gowning and handling of BSL-2 viral vector materials are required.
• Ability to lift and carry up to 50 pounds occasionally and work independently while collaborating with Quality, Manufacturing, Facilities, and CDMO partners.

Nice to have

• Master’s degree in Chemical Engineering, Bioengineering, Biotechnology, or a related field.
• Cross-training across upstream, harvest, downstream purification, and formulation/fill operations.
• Familiarity with JMP or similar statistical software.

Culture & Benefits

• Collaborative environment with opportunities to work across different company functions.
• Professional development opportunities within a growing biopharmaceutical company.
• Medical, dental, and vision plan options, health and financial wellness programs, and an employee assistance program.
• 401(k) retirement plan with company match, flexible spending accounts, life and disability insurance, and education savings benefits.
• Paid time off, holidays, employee discounts, legal services, identity theft protection, pet insurance, and related perks.