Director, Technical Operations (Small Molecule Drug Substance)

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

At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence.

At our site, you’ll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.

Director and Technical Operations Leader

Must bring deep and exceptional expertise in Small Molecule Drug Substance technical operations, including strong understanding of manufacturing processes, equipment, process engineering, scale-up, validation, and troubleshooting, as well as facility systems and their intersections with specific product and process requirements. The individual should have broad experience across the product lifecycle, including tech transfer, continued process verification, and lifecycle management, enabling sound judgment and confident decision-making in a highly regulated environment.

Ideal Candidate

Demonstrates strong leadership and cross-functional collaboration across Science and Technology, Operations, Quality, Supply Chain, and Regulatory functions. They must have the technical operations depth and leadership capability to drive right-first-time execution, support deviation reduction, root cause analysis, CAPA effectiveness, and reliability improvements, while ensuring stable, compliant supply and strong site performance.

Leadership Requirements

This role requires a leader who can combine technical operations mastery with the ability to build and lead teams, influence, develop people, and drive decisions that support technical and operational excellence, GMP compliance, regulatory readiness, data integrity, and audit readiness.

Technical Operations Subject Matter Expertise