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Director, Technical Operations; Molecule Drug Substance

Job in Elkton, Todd County, Kentucky, 42220, USA
Listing for: Biopharma Careers
Full Time position
Listed on 2026-09-03
Job specializations:
  • Automotive
    Regulatory Compliance Specialist, Operations Management, Quality Engineering
Salary/Wage Range or Industry Benchmark: 180000 - 240000 USD Yearly USD 180000.00 240000.00 YEAR
Job Description & How to Apply Below
Position: Director, Technical Operations (Small Molecule Drug Substance)
Location: Elkton

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#J-18808-Ljbffr
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