Process Engineer II — Gene Therapy Scale-Up & Transfer

Asklepios BioPharmaceutical, Inc. (AskBio); North Carolina; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

On-site at RTP

Competitive benefits

Job summary

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

You will support scale-up, technology transfer of gene therapy products into cGMP manufacturing for clinical production and commercial launch, and contribute to Phase III readiness. The role requires collaboration across functions to transfer processes, develop small-scale models, document protocols, analyze data, and ensure robust process control strategies.

Qualifications

• Bachelor’s degree in a scientific discipline with 2+ years biopharmaceutical experience, or higher degree.
• Hands-on upstream or downstream biomanufacturing laboratory experience.
• Experience with viral vectors and cGMP manufacturing operations.
• DOE methodology knowledge; JMP software preferred.

Responsibilities

• Collaborate with cross-functional teams to transfer small-scale gene therapy processes into MSAT and scale-up to cGMP manufacturing.
• Perform process characterization to define robustness and the process control strategy for PPQ campaigns.
• Develop and qualify small-scale models predictive of cGMP scale.
• Author protocols and reports; present results to stakeholders.
• Support investigations with data-driven root-cause analyses.

Skills

Upstream biomanufacturing

Downstream biomanufacturing

Viral vectors

DOE design of experiments

Data-driven problem solving

Strong communication

Travel up to 10%

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

Microsoft Office Suite (Excel, Word, PowerPoint)

Job description

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

You will support scale-up, technology transfer of gene therapy products into cGMP manufacturing for clinical production and commercial launch, and contribute to Phase III readiness. The role requires collaboration across functions to transfer processes, develop small-scale models, document protocols, analyze data, and ensure robust process control strategies.