Director, Aseptic DP Process Engineering

Scorpion Therapeutics; Wilson (NC); On-site; USD 220,000 - 360,000; Full time

Job summary

Scorpion Therapeutics is seeking a Director of Aseptic Drug Product Process Engineering to lead the design and readiness of a new biotherapeutics manufacturing facility in Wilson, NC. You will oversee end-to-end process development, commissioning, and regulatory alignment across global standards.

The role requires deep aseptic manufacturing knowledge, strong leadership, and ability to drive capital projects from greenfield concept through start-up, with significant travel during development.

Qualifications

• Bachelor’s degree in Mechanical or Chemical Engineering.
• 15+ years in biotherapeutic drug product process engineering within a cGMP environment.
• At least 5 years in leadership roles.

Responsibilities

• Develop process specifications.
• Assess vendor capabilities.
• Troubleshoot during commissioning.
• Coordinate across manufacturing, facilities, quality, and engineering teams.
• Ensure compliance with cGMP, EHS, and regulatory standards (EU, FDA).
• Drive project execution, technical excellence, and team development with emphasis on facility design, process validation, and continuous improvement.

Skills

Project management

Vendor assessment

Problem solving

Cross-functional collaboration

Education

Bachelor’s in Mechanical or Chemical Engineering

Job description

Role:

Director of Aseptic Drug Product Process Engineering for a new biotherapeutics manufacturing facility at Johnson & Johnson, leading end-to-end process design and operational readiness.

Responsibilities:

• Develop process specifications
• Assess vendor capabilities
• Troubleshoot during commissioning
• Coordinate across manufacturing, facilities, quality, and engineering teams
• Ensure compliance with cGMP, EHS, and regulatory standards (EU, FDA)
• Drive project execution, technical excellence, and team development, with a focus on facility design, process validation, and continuous improvement

Qualifications:

• Minimum of a Bachelor's in Mechanical or Chemical Engineering
• 15+ years in biotherapeutic drug product process engineering within a cGMP environment
• At least 5 years in leadership roles
• Experience in capital projects (preferably $250-500M), greenfield site development, and facility start-up
• Deep knowledge of aseptic manufacturing standards, EU Annex 1, and regulatory requirements
• Skills include project management, vendor assessment, complex problem-solving, and cross-functional collaboration

High-Value Specifics:

High-value specifics: biologics, biotherapeutics, cGMP, aseptic manufacturing, facility design, commissioning & qualification, regulatory compliance, and international standards.

Location:

Wilson, North Carolina, with >75% travel during project development.