Description

You will apply engineering principles to resolve process issues, evaluate improvements, and support technology transfer for drug products.

This role is on-site.

Responsibilities

• Design and execute experiments to characterize new capabilities, including filling, lyophilization, and analytical technologies.
• Support technology transfer leads during clinical and commercial transfers, including make-a-batch exercises and change control assessments.
• Conduct statistical analysis of generated data using tools like Minitab and JMP.
• Author, review, and verify technical documents such as protocols, assessments, reports, and standard operating procedures.
• Develop digital tools and models leveraging data analytics, programming, and AI.

Required Skills

• Bachelor's degree in engineering or biotechnology with 3+ years of experience (or M.S. with 0–2 years).
• Familiarity with cGMP and experience in drug product or drug substance manufacturing/process development.
• Hands-on experience with various drug product technologies.
• Proficiency in statistical analysis using Minitab or JMP.
• Experience with data analytics, programming, and AI for digital tool development.
• Strong project management and cross-functional communication skills.
• Ability to work independently, manage multiple tasks, and maintain accurate records.

Key Skills

Education

Bachelor's degree