Aseptic Operations Lead – Sterile Filling & CGMP

Glenmarkpharma; Monroe (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

Glenmarkpharma in Monroe, NC seeks an Associate Aseptic Manager to drive manufacturing floor activities including solution preparation, aseptic filtration, and sterile filling for development and commercial distribution.

You will partner with aseptic supervisors and technicians, own compounding areas, ensure CGMP compliance, and lead quality and efficiency initiatives while supporting audits and cross-functional teams.

Qualifications

• Bachelor degree required.
• 10–12 years CGMP/aseptic operations experience.
• Knowledge of FDA CGMP guidelines and aseptic processing.

Responsibilities

• Interface with FDA during site audits.
• Lead production floor in compounding, sterilization, and filling.
• Maintain CGMP documentation and batch records.
• Coordinate with cross-functional groups to meet production demands.
• Lead risk assessment activities (FMEA, HACCP).

Skills

Mechanical Aptitude

Process SME

FDA/CGMP knowledge

Education

Bachelor Degree

Job description

Glenmarkpharma in Monroe, NC seeks an Associate Aseptic Manager to drive manufacturing floor activities including solution preparation, aseptic filtration, and sterile filling for development and commercial distribution.

You will partner with aseptic supervisors and technicians, own compounding areas, ensure CGMP compliance, and lead quality and efficiency initiatives while supporting audits and cross-functional teams.