Small Molecule Manufacturing Operations Lead

Biopharma Careers; Elkton (KY); On-site; USD 96,000 - 151,000; Full time

Job summary

Merck & Co., Inc. seeks an API Operations Specialist to support commissioning, qualification, start-up, and readiness for a new small molecule facility in Elkton, VA.

You will coordinate across Operations, Engineering, Quality, and Supply Chain to ensure safe, compliant startup and efficient production. The role emphasizes continuous improvement, Lean/Kaizen practices, and strong problem-solving within a GMP framework.

Qualifications

• Bachelor’s degree preferred in Chemical Engineering, Pharmaceutical Engineering, Biochemical Engineering, Chemistry, or a related technical discipline.
• Minimum 5 years of experience in API Small Molecule manufacturing to include operations or technical operations.
• Experience working in a cross-functional manufacturing, technical, or operational setting.
• Experience contributing to operational improvement, troubleshooting, process support, or start-up-related activities.
• Working knowledge of GMP, quality, and compliance expectations in pharmaceutical manufacturing.
• Strong problem-solving, communication, collaboration, and organizational skills.
• Ability to work effectively across Operations, Engineering, Quality, and Technical teams.
• Ability to prioritize work in a dynamic, fast-paced environment.
• Demonstrated commitment to safety, operational excellence, and continuous improvement.

Responsibilities

• Support commissioning, qualification, start-up, and operational readiness activities for the new API Small Molecule facility in Elkton, VA.
• Partner with Operations, Engineering, Quality, Technical Operations, Supply Chain, and other stakeholders to support safe, compliant, and effective plant start-up.
• Provide technical and operational support during equipment and process start-up, troubleshooting, and optimization activities.
• Support technology transfer and implementation of commercial manufacturing processes into the new facility.
• Help define, implement, and improve operating practices, standard work, procedures, and routines that support reliable and compliant operations.
• Coordinate and prioritize improvement activities and key areas of focus within the IPT in alignment with business objectives and operational performance goals.
• Use our company Production System (MPS) tools and lean principles, including Kaizen, 5S, visual management, and Standard Work, to identify and support improvement opportunities.
• Help embed best practices across shifts, functions, and workstreams to promote consistency, efficiency, and strong operational execution.
• Support a culture of safety, quality, compliance, accountability, and continuous improvement.
• Act as a delegate for the Production Lead when needed, supporting continuity of leadership and cross-functional coordination.
• Contribute to an inclusive, collaborative, and performance-driven work environment.

Skills

Adaptability

Analytical Problem Solving

Biopharmaceutical Industry

cGMP Compliance

Data Analysis

Decision Making

GMP Compliance

Inventory Management

Lean Management

Lean Process Improvements

Lean Six Sigma Continuous Improvement

Manufacturing Environments

Manufacturing Operations

Manufacturing Technologies

Operational Excellence

Personal Initiative

Pharmaceutical Manufacturing

Pharmaceutical Process Engineering

Process Improvements

Process Optimization

Production Planning

Production Scheduling

Project Manufacturing

Technology Transfer

Education

Bachelor’s degree preferred in Chemical Engineering, Pharmaceutical Engineering, Biochemical Engineering, Chemistry, or a related technical discipline

Job description

Merck & Co., Inc. seeks an API Operations Specialist to support commissioning, qualification, start-up, and readiness for a new small molecule facility in Elkton, VA.

You will coordinate across Operations, Engineering, Quality, and Supply Chain to ensure safe, compliant startup and efficient production. The role emphasizes continuous improvement, Lean/Kaizen practices, and strong problem-solving within a GMP framework.