Director of Small Molecule Technical Operations

Merck; Elkton (VA); On-site; USD 180,000 - 240,000; Full time

Job summary

Merck is seeking a Director and Technical Operations Leader to guide small molecule drug substance operations, including process engineering, scale‑up, validation, and tech transfer. The role requires deep GMP knowledge, regulatory readiness, and cross‑functional leadership to ensure safe, compliant, and reliable supply for a high‑stakes biopharmaceutical manufacturing site in the U.S.

The ideal candidate will oversee site operations, drive right‑first‑time execution, and lead improvements

Qualifications

• Bachelor's degree in science or engineering required.
• Advanced degree in chemistry, chemical engineering or related discipline preferred.
• 10+ years in small molecule drug substance process development or manufacturing operations.
• 7+ years with advanced degree; experience in tech transfer, PPQ, scale-up and lifecycle management.

Responsibilities

• Owns site-level product introductions and tech transfer strategy and execution.
• Ensures end-to-end risk assessment, control strategy alignment and on-time introductions.
• Leads corrective actions and continuous improvement across GMP and data integrity.
• Partners with Quality, Regulatory and Supply Chain to ensure compliant, reliable supply.

Skills

Cross-Functional Leadership

Quality Systems

GMP Compliance

Process Safety

Technical Issues

Technology Transfer

Problem Solving

Education

Bachelor's Degree in Science or Engineering

Advanced degree in Chemistry or Chemical Engineering or related

Job description

Merck is seeking a Director and Technical Operations Leader to guide small molecule drug substance operations, including process engineering, scale‑up, validation, and tech transfer. The role requires deep GMP knowledge, regulatory readiness, and cross‑functional leadership to ensure safe, compliant, and reliable supply for a high‑stakes biopharmaceutical manufacturing site in the U.S.

The ideal candidate will oversee site operations, drive right‑first‑time execution, and lead improvements