Associate Director, Process Development - Large Molecules

Merck; Omaha (NE); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck & Co., Inc. in the United States is seeking an Associate Director for Process Development in Large Molecules. The role leads a high-performing team, ensuring robust processes and timely transfers from R&D to operations, across regulatory, quality, and manufacturing interfaces.

The position emphasizes strategic initiative oversight, risk management, and strong collaboration within a matrix organization to enable reliable product supply and launches.

Qualifications

• Bachelor’s degree with 8+ years post-graduate experience OR Master’s with 6+ years OR Doctoral degree with 4+ years of post-graduate experience
• Minimum of 3 years of direct management experience
• Minimum four (4) years of relevant experience in technology transfer, process development, technical operations, or manufacturing operations within a regulated biopharmaceutical environment
• Demonstrate as an effective project leader who can maintain oversight, manage priorities, and deliver on-time results in a complex, fast-paced matrix organization
• Strong working knowledge of EMA, FDA, and/or USDA regulations and guidelines
• Demonstrated commitment to Diversity, Equity, & Inclusion

Responsibilities

• Process Development – Develops robust processes and leads technology transfer from R&D to operations for antigens and finished products. Collaborates with R&D, operations, quality and regulatory to ensure files/launches on time.
• People Management – Builds and sustains a high-performing technology transfer team with clear objectives, feedback, development plans and succession strategies.
• Technical Excellence – Makes data-driven decisions, drives process improvements, and manages risk mitigation methods (e.g., FMEA) to improve robustness and reduce costs.
• Strategic Leadership – Manages strategic initiatives and aligns team goals with regional technology strategy.

Skills

Biopharmaceutical Industry

Coaching Employees

Decision Making

People Leadership

Process Development

Technical Operations

Technology Transfer

Education

Bachelor of Science in Chemical Engineering, Biotechnology, Biochemistry, Protein Chemistry, Biology or related field

Job description

Merck & Co., Inc. in the United States is seeking an Associate Director for Process Development in Large Molecules. The role leads a high-performing team, ensuring robust processes and timely transfers from R&D to operations, across regulatory, quality, and manufacturing interfaces.

The position emphasizes strategic initiative oversight, risk management, and strong collaboration within a matrix organization to enable reliable product supply and launches.