MSAT Process Engineer II - Gene Therapy Scale-Up

NCBiotech; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

AskBio Inc. is seeking a Process Engineer II to join the MSAT Process Engineering team and support scale-up and technology transfer of gene therapy products into cGMP manufacturing for clinical production, process validation, and commercial launch.

The role requires coordinating scale-up, transfer, and PPQ readiness, with collaboration across internal and external teams to ensure compliant, timely supply."

Qualifications

• Bachelor’s degree or higher in a scientific field with biopharma experience.
• Hands-on upstream or downstream biomanufacturing laboratory experience.
• Excellent written and verbal communication and collaboration skills.
• Willingness to travel up to 10% domestically/internationally.

Responsibilities

• Transfer small-scale gene therapy processes into MSAT lab and scale up to cGMP scale.
• Characterize processes to define the PPQ control strategy.
• Develop and qualify small-scale models predictive of the cGMP scale.
• Author technical protocols and reports; maintain electronic laboratory notebooks.
• Communicate results in technical presentations to internal stakeholders.
• Support investigations with data-driven root-cause analyses.
• Ensure lab is clean, organized, and maintained; schedule maintenance.

Skills

Excellent written and verbal沟通 skills

MS Office proficiency

Team collaboration

Problem solving

Education

Bachelor’s Degree in a scientific discipline

Master’s Degree in a scientific discipline

High School Diploma with 6+ years biopharmaceutical Experience

Tools

JMP Statistical Software

Job description

AskBio Inc. is seeking a Process Engineer II to join the MSAT Process Engineering team and support scale-up and technology transfer of gene therapy products into cGMP manufacturing for clinical production, process validation, and commercial launch.

The role requires coordinating scale-up, transfer, and PPQ readiness, with collaboration across internal and external teams to ensure compliant, timely supply."