Process Engineer

Job Title: Bioprocess Research Associate (AAV Gene Therapy)
Industry: Biotechnology
Location: Research Triangle Park, NC

Duration:12 months

Client Overview

Our client is a gene therapy company headquartered in Research Triangle Park and owned by a global pharmaceutical and life sciences company. It develops AAV-based gene therapies using its own proprietary cell line manufacturing platform, with programs ranging from early research to late-stage clinical trials. This role supports the team that makes vector material for research and GLP studies.

Top 3 Skills

• Upstream bioprocessing: mammalian cell culture and vector production in shake flasks, rocking-motion bioreactors, and stirred-tank bioreactors
• Downstream purification: centrifugation, filtration, and chromatography
• Protocol- and batch-record-driven execution with real-time GLP and GDP documentation

What You'll Do

• Run defined rAAV manufacturing and lab activities for research and GLP-grade studies, following protocols and batch records
• Grow and maintain cell cultures, and produce vector at small and pilot scale
• Run centrifugation, filtration, chromatography, and related purification steps
• Execute process characterization and robustness experiments assigned by MSAT and process development scientists
• Record lab work and data in real time in paper or electronic systems, and help complete and review batch records
• Run confirmatory experiments and collect data to support manufacturing investigations
• Help write technical protocols, experiment reports, and summary presentations
• Set up, operate, and maintain lab equipment, and keep the lab inspection-ready
• Coordinate materials, consumables, and reagents with lab management and solution prep teams
• Share progress and results with project stakeholders

What We Need From You

• A BS in biotechnology, chemistry, biochemistry, or chemical or biochemical engineering with 2+ years of lab research or biologics manufacturing experience, or an MS in one of those fields with any amount of experience
• Hands-on experience with upstream or downstream bioprocess operations
• Experience executing experiments under direction from protocols and batch records, with accurate documentation
• Ability to work fully onsite in Research Triangle Park, including periodic weekend coverage
• A desire to stay in a hands-on, lab-focused role rather than a design or management track

Preferred / Bonus

• AAV or other viral vector production experience
• cGMP manufacturing or manufacturing-support lab experience
• WAVE bioreactor or stirred-tank bioreactor experience, including scale-up, scale-down, or process characterization runs
• Background in MSAT, process development, or biologics manufacturing
• Familiarity with DOE execution
• JMP or a similar statistical tool