Process Engineer, Drug Substance Manufacturing – Gene Therapy

Precigen; Germantown, Northern (MD, KY); Hybrid; USD 90,000 - 110,000; Full time

Job summary

Precigen in Germantown, MD seeks a Process Engineer for Drug Substance Manufacturing to support gene therapy production from tech transfer to cGMP operations. The role emphasizes end-to-end technical troubleshooting, process optimization, and collaboration across Development, QA, and Manufacturing teams.

The ideal candidate has hands-on biopharma experience, expertise in process engineering of drug substance, and a proactive mindset to drive continuous improvements in a fast-paced manufacturing

Qualifications

• B.Sc or M.Sc in Chemical Engineering, Bioengineering, or related field.
• 3-4 years in a biopharmaceutical manufacturing setting with process changes/optimization and tech transfer.
• Experience in Drug substance process development/engineering.
• Strong data analysis and ability to present technical reports.

Responsibilities

• Provide end-to-end technical support of gene therapy Drug Substance manufacturing.
• Support facility design, construction, commissioning, and startup projects.
• Collaborate cross-functionally to transfer, implement and maintain processes at multiple facilities.
• Provide on-the-floor technical oversight during product campaigns and troubleshooting.
• Trend process data, perform capability assessments, and drive continuous improvement.
• Author/review technical reports, transfer summaries, risk assessments, and protocols.
• Support investigations and determine root cause and corrective actions.
• Review project plans and regulatory submissions related to process understanding and validation.

Skills

Process engineering

Data analysis

Problem solving

Cross-functional collaboration

Education

B.Sc or M.Sc in Chemical Engineering, Bioengineering, or related engineering degree

Tools

Excel

JMP

Job description

Precigen in Germantown, MD seeks a Process Engineer for Drug Substance Manufacturing to support gene therapy production from tech transfer to cGMP operations. The role emphasizes end-to-end technical troubleshooting, process optimization, and collaboration across Development, QA, and Manufacturing teams.

The ideal candidate has hands-on biopharma experience, expertise in process engineering of drug substance, and a proactive mindset to drive continuous improvements in a fast-paced manufacturing