Process Engineer - Drug Substance

Scorpion Therapeutics; Germantown (MD); On-site; USD 110,000 - 150,000; Full time

Job summary

Scorpion Therapeutics is seeking a Process Engineer to support gene therapy Drug Substance manufacturing from clinical to commercial stages. You will drive technical excellence in manufacturing, process transfer, validation, and facility startup for Adenovector products.

You will provide end-to-end process engineering support, collaborate across departments, oversee data trending, and author critical technical reports and protocols while assisting regulatory documentation and troubleshooting

Qualifications

• 3-4 years biopharma manufacturing experience with process development, technology transfer, and process support.
• Experience in data analysis, technical report writing, and process optimization.

Responsibilities

• provide end-to-end process engineering support
• collaborate across departments (Process Development, QC, QA, Supply Chain, CMOs)
• oversee process data trending and continuous improvement
• author technical reports and protocols
• troubleshoot production issues
• assist regulatory documentation

Skills

Process engineering

Data analysis

Technical report writing

Process optimization

Cross-functional collaboration

Mentoring

Education

B.Sc in Chemical Engineering, Bioengineering, Biotechnology, or related

M.Sc in Chemical Engineering, Bioengineering, Biotechnology, or related

Job description

Role

Process Engineer supporting gene therapy Drug Substance manufacturing from clinical to commercial stages. Objectives: ensure technical excellence in manufacturing, process transfer, validation, and facility startup for Adenovector products.

Responsibilities

• provide end-to-end process engineering support
• collaborate across departments (Process Development, QC, QA, Supply Chain, CMOs)
• oversee process data trending and continuous improvement
• author technical reports and protocols
• troubleshoot production issues
• assist regulatory documentation

Qualifications

• B.Sc or M.Sc in Chemical Engineering, Bioengineering, Biotechnology, or related
• 3-4 years biopharma manufacturing experience with process development, technology transfer, and process support; skilled in data analysis, technical report writing, and process optimization

Preferred Skills

• experience with viral vectors/vaccines
• facility design
• operational excellence
• mentoring

HighValue

• gene therapy (Adenovector)
• viral vector manufacturing
• process validation
• process transfer
• regulatory support
• cGMP environment
• clinical to commercial phases

WorkSetup

• not specified; likely on-site with cross-functional collaboration