BioProcess Engineer II, Downstream (Gene Therapy)

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

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

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 and provide technical expertise for downstream viral vector purification operations, including clarification, nuclease treatment, tangential flow filtration, chromatography, formulation, buffer exchange, and sterile filtration.
• Design and execute process development, optimization, characterization, and DOE experiments to improve yield, impurity clearance, and product quality.
• Develop filtration and chromatography operations, including filter sizing, membrane selection, column packing, qualification, resin lifetime, and cleaning strategies.
• Lead process scale-up from bench through pilot and cGMP manufacturing scale and develop scale-down models for troubleshooting and robustness studies.
• Support technology transfer, GMP manufacturing, equipment qualification, validation, deviations, investigations, root cause analysis, and corrective and preventive actions.
• Prepare and review batch records, SOPs, 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 relevant experience.
• Hands-on experience with viral vector purification for gene therapy applications and downstream biopharmaceutical process development or cGMP manufacturing.
• Industrial or cGMP experience with clarification, tangential flow filtration, sterile filtration, and process-scale chromatography.
• Expertise with affinity and anion exchange chromatography, other chromatography modes, ÄKTA systems, UNICORN software, column qualification, and chromatography scale-up.
• Knowledge of gene therapy product quality attributes, cGMP aseptic manufacturing, relevant FDA/ICH/USP guidance, and in-process and release analytics.
• Ability to work in laboratories, manufacturing areas, warehouses, and classified cleanrooms, including BSL-2 environments; ability to gown and lift up to 50 pounds occasionally.

Nice to have

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

Culture & Benefits

• Collaborative work across process development, quality, manufacturing, facilities, and other functions.
• Professional development opportunities within a growing biotechnology company.
• Medical, dental, and vision plan options, health and financial wellness programs, and employee assistance resources.
• 401(k) plan with company match, flexible spending accounts, paid life and disability coverage, and education savings options.
• Paid time off, holidays, health pay, personal days, cultural days, and additional employee discounts and protection programs.