Principal Technical Lead, External Manufacturing - Drug Substance

📋 Description

• Serve as the primary technical representative to external manufacturing partners for assigned
• Maintain detailed understanding of manufacturing processes, critical process parameters, critical
• Review manufacturing performance and identify process trends, risks, variability, and opportunities
• Provide technical leadership for manufacturing deviations, investigations, root-cause analysis
• Assess the technical impact of manufacturing changes, including equipment, raw materials, process
• Lead or support technology transfers, process scale-up, process validation (PPQ), continued process

🎯 Requirements

• BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent
• Demonstrated experience with GMP drug-substance manufacturing, process characterization, and
• Comfortability in making technical decisions and influencing external partners and senior internal

🎁 Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Long-term incentive programs