Aseptic Operations Manager — GMP & FDA-Ready Leader

Glenmark Pharmaceuticals; Monroe (NC); On-site; USD 120,000 - 170,000; Full time

Job summary

Glenmark Pharmaceuticals in the United States seeks an Aseptic Manufacturing Manager to lead production supervisors and technicians in aseptic filling, solution compounding and equipment preparation for sterile liquids used in development and commercial distribution.

The role requires expert aseptic technique, CGMP knowledge, and coordination with site leadership to meet production schedules, quality standards, and regulatory expectations.

Qualifications

• Bachelor degree required.
• 5–8 years CGMP/aseptic operations experience.
• Knowledge of FDA CGMP and aseptic processing.

Responsibilities

• Lead a team of production supervisors, team leads and technicians.
• Act as liaison between site senior leadership and the floor.
• Review, correct and close out area-specific batch records within expected release timeframe.
• Develop, revise and approve CGMP protocols, SOPs, BMRs and risk assessments.
• Identify deviations in real time and document investigations in the QMS.
• Maintain auditable production environments and ensure readiness for audits.

Skills

Aseptic technique

Team leadership

CGMP knowledge

FDA liaison

Education

Bachelor's degree

Tools

QMS

Job description

Glenmark Pharmaceuticals in the United States seeks an Aseptic Manufacturing Manager to lead production supervisors and technicians in aseptic filling, solution compounding and equipment preparation for sterile liquids used in development and commercial distribution.

The role requires expert aseptic technique, CGMP knowledge, and coordination with site leadership to meet production schedules, quality standards, and regulatory expectations.