MSAT Process Engineer II: Gene Therapy Scale-Up & Transfer

askbio; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

AskBio Inc. is seeking a Process Engineer II to join the MSAT Process Engineering team at the RTP, NC campus.

This role supports scale-up, tech transfer of gene therapy products into cGMP manufacturing, process validation, and PPQ readiness for both drug substance and drug product. The incumbent will onboard clinical programs, perform scale-up runs, and transfer programs to the contract manufacturing facility.

Qualifications

• Bachelor’s Degree in a scientific discipline required; 2+ years biopharmaceutical experience in lab settings.
• Hands-on upstream or downstream biomanufacturing laboratory experience.
• Excellent written and verbal communication skills with diverse stakeholders.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Highly motivated, organized, and collaborative in a fast-paced tech transfer team.
• Willingness to travel domestically and internationally up to ~10%.

Responsibilities

• Transfer small-scale gene therapy processes from Process Development to MSAT lab.
• Generate robustness data and define the PPQ process control strategy.
• Develop and qualify small-scale models predictive of cGMP scale.
• Prepare technical protocols and reports with organized ELN records.
• Communicate results to internal stakeholders through technical presentations.
• Contribute to root-cause analyses and data-driven issue resolution.

Skills

Biopharmaceutical experience

Communication skills

Microsoft Office

Team collaboration

Problem solving

Willingness to travel

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 Software

Job description

AskBio Inc. is seeking a Process Engineer II to join the MSAT Process Engineering team at the RTP, NC campus.

This role supports scale-up, tech transfer of gene therapy products into cGMP manufacturing, process validation, and PPQ readiness for both drug substance and drug product. The incumbent will onboard clinical programs, perform scale-up runs, and transfer programs to the contract manufacturing facility.