Process Engineer

ALOIS Solutions; Durham (NC); Presencial; USD 75.000 - 95.000; Jornada completa

Descripción de la vacante

ALOIS Solutions in Durham, NC seeks a hands-on Process Engineer / Research Associate to support rAAV vector research, process development, and late-stage clinical gene therapy programs in a lab and manufacturing setting. This execution-focused role emphasizes hands-on laboratory work, experimental execution, bioprocessing, and collaboration with Manufacturing and MSAT teams.

Key duties include rAAV manufacturing, upstream/downstream processing, data documentation, batch records, DOE/JMP

Formación

• BS or MS in Biotechnology, Chemistry, Biochemistry, Chemical/Biochemical Engineering, or related discipline.
• BS: 2+ years relevant experience | MS: 0+ years relevant experience
• Experience or familiarity with upstream and/or downstream bioprocessing
• Comfortable executing experiments according to established protocols
• Strong attention to detail and data accuracy
• Ability to work onsite in a fast-paced laboratory environment
• cGMP manufacturing or manufacturing-support laboratory experience
• Process characterization / scale-up / scale-down experience
• Familiarity with DOE concepts
• Experience with JMP or similar statistical tools
• Experience supporting biologics manufacturing or MSAT activities
• Flexibility to support occasional weekend manufacturing/lab schedules

Responsabilidades

• Execute routine rAAV manufacturing and laboratory activities following established protocols and batch records
• Perform upstream & downstream bioprocessing, including cell culture, vector production, centrifugation, filtration, and chromatography
• Work with shake flasks, WAVE bioreactors and/or stirred-tank bioreactors
• Execute process development, characterization, robustness, and scale-up/scale-down studies
• Maintain accurate laboratory, experimental, and manufacturing documentation
• Support batch records, data compilation, investigations, troubleshooting, and root-cause activities
• Prepare technical protocols, reports, and presentations
• Support laboratory equipment setup, operation, maintenance, and day-to-day lab activities
• Follow all SOP, safety, quality, and data integrity requirements

Conocimientos

Bioprocessing

Lab Execution

Data Analysis

Documentation

Attention to Detail

On-site Work

Educación

Biotechnology or Chemistry degree

Chemical/Biochemical Engineering degree

Herramientas

JMP

Descripción del empleo

We’re looking for a hands-on Process Engineer / Research Associate to support AAV (rAAV) vector research, process development, and late-stage clinical gene therapy programs within a laboratory and manufacturing environment.

This is an execution-focused opportunity for someone who enjoys hands‑on laboratory work, experimental execution, bioprocessing, and working closely with Manufacturing and MSAT teams.

• Execute routine rAAV manufacturing and laboratory activities following established protocols and batch records
• Perform upstream & downstream bioprocessing, including cell culture, vector production, centrifugation, filtration, and chromatography
• Work with shake flasks, WAVE bioreactors and/or stirred-tank bioreactors
• Execute process development, characterization, robustness, and scale-up/scale-down studies
• Maintain accurate laboratory, experimental, and manufacturing documentation
• Support batch records, data compilation, investigations, troubleshooting, and root-cause activities
• Prepare technical protocols, reports, and presentations
• Support laboratory equipment setup, operation, maintenance, and day-to-day lab activities
• Follow all SOP, safety, quality, and data integrity requirements

Required Qualifications

• BS or MS in Biotechnology, Chemistry, Biochemistry, Chemical/Biochemical Engineering, or related discipline
• BS: 2+ years relevant experience | MS: 0+ years relevant experience
• Experience or familiarity with upstream and/or downstream bioprocessing
• Comfortable executing experiments according to established protocols
• Strong attention to detail and data accuracy
• Ability to work onsite in a fast-paced laboratory environment
• cGMP manufacturing or manufacturing-support laboratory experience
• Process characterization / scale-up / scale-down experience
• Familiarity with DOE concepts
• Experience with JMP or similar statistical tools
• Experience supporting biologics manufacturing or MSAT activities
• Flexibility to support occasional weekend manufacturing/lab schedules

Ideal Profile:

Someone who is hands‑on, execution-oriented, organized, technically curious, and comfortable working under established protocols while collaborating with scientists, engineers, and manufacturing teams.