Associate Director, Drug Substance Ops & Tech Transfer

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

Job summary

MSD in Elkton, Virginia, seeks an Associate Director, Technical Operations – Drug Substance to provide technical leadership across API startup, technology transfer, validation, and ongoing commercial manufacture. The role emphasizes safe, compliant, and reliable process performance with accountability for scale-up and lifecycle management.

The position requires strong cross-functional collaboration, deep process chemistry expertise, and a commitment to continuous improvement and operational

Qualifications

• Degree (BSc/BEng/Masters) or higher in Chemistry, Chemical Engineering, or related discipline
• Significant experience (typically 10+ years) in API process development and/or manufacturing
• Strong background in Process chemistry and scale-up
• Process, equipment, and cleaning validation

Responsibilities

• Lead technical leadership for Drug Substance processes, including synthesis, purification, crystallization, and drying
• Lead technology transfer and validation activities across sites
• Drive continuous improvements in process performance, yield, and impurity control
• Ensure compliance with cGMP and regulatory expectations
• Collaborate with Engineering, Capital Projects, R&D, Quality, Supply Chain, and Manufacturing

Skills

Technical leadership

API manufacturing

Process scale-up

Technology transfer

Regulatory compliance

Education

BSc in Chemistry or Chemical Engineering

MSc/PhD preferred

Tools

Process validation

Job description

MSD in Elkton, Virginia, seeks an Associate Director, Technical Operations – Drug Substance to provide technical leadership across API startup, technology transfer, validation, and ongoing commercial manufacture. The role emphasizes safe, compliant, and reliable process performance with accountability for scale-up and lifecycle management.

The position requires strong cross-functional collaboration, deep process chemistry expertise, and a commitment to continuous improvement and operational