Senior Specialist, Engineering- Biologics External Manufacturing Technical Operations

Scorpion Therapeutics; Pennsylvania; On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Travel 25%

Job summary

Scorpion Therapeutics seeks a Senior Specialist in Engineering for Biologics External Manufacturing Technical Operations to lead drug substance tech transfer and commercial production within the external manufacturing network. You will act as the primary interface with external partner drug substance manufacturers, author GMP documentation, drive process improvements, and support regulatory inspections.

This role emphasizes GMP compliance and inspection readiness, with a focus on standardized

Qualifications

• Bachelor's degree in a chemical/biochemical engineering, pharmaceutical science, chemistry, or related field.
• 8+ years post-bachelor GMP experience in operations, engineering, or technical support.
• Strong problem-solving, communication, and organizational skills.
• Ability to work independently and multi-task under tight deadlines.

Responsibilities

• Lead technical transfer activities in biologics external manufacturing.
• Serve as primary interface with external partner drug substance manufacturers.
• Author and review GMP documentation.
• Manage process improvements and support regulatory inspections.
• Ensure external partners meet GMP compliance and inspection readiness.
• Develop standardized work and drive continuous technical excellence.

Education

Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry, or related field

Job description

Role:

Senior Specialist in Engineering for Biologics External Manufacturing Technical Operations, focusing on drug substance tech transfer and commercial production within the external manufacturing network.

Responsibilities:

lead technical transfer activities, serve as primary interface with external partner drug substance manufacturers, author/review GMP documentation, manage process improvements, and support regulatory inspections. Ensure external partners meet GMP compliance and inspection readiness, develop standardized work, and drive continuous technical excellence.

Requirements:

Bachelor's in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry, or related field; 8+ years post-bachelor's GMP experience in operations, engineering, or technical support; strong problem-solving, communication, and organizational skills; ability to work independently and multi-task under tight deadlines.

Preferred:

experience in biologics or large molecule manufacturing, project management, deviation/change management, and knowledge of global regulatory requirements.

High Value:

biologics/vaccines manufacturing, drug substance tech transfer, GMP compliance, sterile processes, regulatory support, 25% travel.

Work Setup:

in-office with travel.