Process Engineer - Drug Substance Production (Gene Therapy)

Precigen, Inc; Germantown (MD); On-site; USD 90,000 - 110,000; Full time

Job summary

Precigen, Inc. in Germantown, MD is seeking a Process Engineer – Drug Substance Manufacturing to support gene therapy manufacturing processes from transfer to commercialization.

The role requires technical expertise, collaboration across multiple teams, and hands-on problem solving to optimize drug substance production. Responsibilities include supporting facility design/startup, process transfers, data trending, and regulatory filings, with a strong emphasis on cGMP drug substance operations

Qualifications

• B.Sc or M.Sc in Chemical Engineering, Bioengineering, or another relevant engineering degree.
• 3-4 years of experience in a biopharmaceutical manufacturing setting with process changes/optimization, tech transfer, and manufacturing support.
• Experience in process development and/or process engineering of Drug substance.
• Experience summarizing and presenting data, statistical analysis, and authoring technical reports.
• Strong computer skills with Microsoft Office, data trending/management software (Excel and Jmp) and the ability to quickly learn new applications.

Responsibilities

• End-to-end technical support of gene therapy product manufacturing (Drug Substance).
• Provide process engineering support for facility design, construction, commissioning, and startup projects.
• Work cross functionally to transfer, implement and maintain processes at multiple facilities.
• Offer on-the-floor technical oversight through product campaigns and troubleshoot process/equipment issues.
• Collect and trend process data, perform capability assessments, and identify continuous improvement areas.
• Author/review technical reports, tech transfer summaries, risk assessments, and protocols for tech transfer and regulatory filings.
• Support investigations and provide root-cause analysis and corrective actions.
• Review project plans and regulatory submissions related to process understanding and Validation protocols.
• Perform other duties as assigned.

Skills

Process engineering

Data analysis

Tech transfer

Regulatory filings

Education

B.Sc in Chemical Engineering

M.Sc in Bioengineering

Tools

Excel

Jmp

Microsoft Office

Job description

Precigen, Inc. in Germantown, MD is seeking a Process Engineer – Drug Substance Manufacturing to support gene therapy manufacturing processes from transfer to commercialization.

The role requires technical expertise, collaboration across multiple teams, and hands-on problem solving to optimize drug substance production. Responsibilities include supporting facility design/startup, process transfers, data trending, and regulatory filings, with a strong emphasis on cGMP drug substance operations