Director of Small Molecule Technical Operations

Biopharma Careers; Elkton (KY); On-site; USD 180,000 - 240,000; Full time

Job summary

Biopharma Careers seeks a Director and Technical Operations Leader for a premier small molecule manufacturing site in the U.S. You will oversee technical operations, drive process engineering excellence, and ensure quality, safety and regulatory readiness across the product lifecycle.

The role requires strong leadership, collaboration with Science & Technology, Operations, Quality and Regulatory teams, and a track record of lifecycle management and continuous improvement in a highly regulated

Qualifications

• Must bring deep expertise in small molecule drug substance operations across processes, scale-up, validation and troubleshooting.
• Experience with tech transfer, continued process verification and lifecycle management in a regulated environment.
• Ability to lead across Science & Technology, Operations, Quality, Supply Chain and Regulatory functions.

Responsibilities

• Lead and inspire cross-functional teams to drive right-first-time execution.
• Support deviation reduction, root cause analysis and CAPA effectiveness.
• Ensure stable, compliant supply and strong site performance through technical operations leadership.

Skills

Leadership

Cross-functional collaboration

GMP compliance

Regulatory readiness

Data integrity

Audit readiness

Technical operations depth

Job description

Biopharma Careers seeks a Director and Technical Operations Leader for a premier small molecule manufacturing site in the U.S. You will oversee technical operations, drive process engineering excellence, and ensure quality, safety and regulatory readiness across the product lifecycle.

The role requires strong leadership, collaboration with Science & Technology, Operations, Quality and Regulatory teams, and a track record of lifecycle management and continuous improvement in a highly regulated