Associate Director, Large Molecule Process Development

MSD; Elk Horn (IA); On-site; USD 142,000 - 224,000; Full time

Job summary

MSD is seeking an Associate Director in the US to lead process development for large molecule products. You will oversee robust process design, scale-up, and timely technology transfer from R&D to production, coordinating with R&D, operations, quality, and regulatory teams.

The role requires experience directing a tech transfer team, managing project priorities, and ensuring launches meet targets. Strong knowledge of regulatory guidelines and risk management is essential.

Qualifications

• Bachelor’s with post-graduate experience in a relevant field (8+ yrs for BS, 6+ yrs MS, 4+ yrs PhD)
• Minimum 3 years of direct management experience
• 4+ years of experience in technology transfer, process development or manufacturing operations in a regulated biopharmaceutical environment
• Demonstrated project leadership in a complex, matrix organization
• Strong knowledge of EMA, FDA, USDA regulations

Responsibilities

• Develop robust processes and technology transfer of processes from R&D to operations for antigens and final products
• Manage and coach a high-performing technology transfer team
• Drive data-driven decisions and risk mitigation (FMEA) across technology transfers
• Lead strategic initiatives and align goals with regional technology organization

Skills

Process Development

Technology Transfer

People Leadership

Project Management

Decision Making

Biopharmaceutical Industry

Life Sciences R&D

Quality & Regulatory

Operations

Education

BS in Chemical Engineering

Job description

MSD is seeking an Associate Director in the US to lead process development for large molecule products. You will oversee robust process design, scale-up, and timely technology transfer from R&D to production, coordinating with R&D, operations, quality, and regulatory teams.

The role requires experience directing a tech transfer team, managing project priorities, and ensuring launches meet targets. Strong knowledge of regulatory guidelines and risk management is essential.