Aseptic GMP Operations Lead - 1st Shift

MSD Malaysia; Northern (KY); Hybrid; USD 117,000 - 184,000; Full time

Job summary

Merck & Co., Inc., Rahway, NJ, USA is seeking an Operations Manager for the 1st shift in the sterile liquids pilot plant. You will supervise manufacturing teams, ensure compliance with GMP, and drive safety, quality, and on-time delivery in a regulated environment.

The role emphasizes continuous improvement, cross-functional collaboration with Quality, Engineering, Validation, and Supply Chain, and participation in audits and investigations as needed.

Qualifications

• Bachelor’s degree in science or engineering.
• Minimum 3 years of leadership experience in GMP manufacturing or related life science operations.
• Experience supporting FDA/EMA inspections is a plus.
• Strong knowledge of GMP, data integrity and quality systems.

Responsibilities

• Provide first-line supervision of 1st shift manufacturing operations.
• Ensure safety, quality, and regulatory compliance in sterile manufacturing.
• Lead continuous improvement, investigations, and CAPAs in collaboration with Quality and Engineering.

Skills

Biochemical Analysis

Clinical Manufacturing

Dosage Forms

Evaluating New Technologies

Identifying Customer Needs

Medical Knowledge

New Product Research

Patent Commercialization

People Leadership

Pharmaceutical Production

Pharmaceutical Technologies

Pilot Plant Operations

Specification Development

Team Leadership

Education

Bachelor’s degree in science or engineering

Job description

Merck & Co., Inc., Rahway, NJ, USA is seeking an Operations Manager for the 1st shift in the sterile liquids pilot plant. You will supervise manufacturing teams, ensure compliance with GMP, and drive safety, quality, and on-time delivery in a regulated environment.

The role emphasizes continuous improvement, cross-functional collaboration with Quality, Engineering, Validation, and Supply Chain, and participation in audits and investigations as needed.