Aseptic Operations Lead – Sterile Manufacturing

Glenmark Pharmaceuticals; Monroe (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Glenmark Pharmaceuticals seeks an Associate Aseptic Manager to drive manufacturing floor activities, including solution prep, aseptic filtration and filling of sterile liquids for development and commercial distribution. You will partner with floor supervisors and technicians to ensure CGMP compliance and timely production.

You will own compounding, equipment prep and filling areas, mentor staff, and ensure QA/QC alignment while maintaining contamination control and process improvements across

Qualifications

• Bachelor's degree required.
• 10–12 years' experience in CGMP/aseptic operations.

Responsibilities

• Lead production supervisors in compounding, sterilization and filling of drug products.
• Serve as liaison between aseptic operations manager and floor staff.
• Review and close out batch records; maintain CGMP-compliant areas.
• Communicate production needs to cross-functional teams and leadership.
• Identify deviations and document investigations in the QMS.

Skills

CGMP Knowledge

Aseptic Manufacturing

Process SME

FDA Liaison

Education

Bachelor's Degree

Job description

Glenmark Pharmaceuticals seeks an Associate Aseptic Manager to drive manufacturing floor activities, including solution prep, aseptic filtration and filling of sterile liquids for development and commercial distribution. You will partner with floor supervisors and technicians to ensure CGMP compliance and timely production.

You will own compounding, equipment prep and filling areas, mentor staff, and ensure QA/QC alignment while maintaining contamination control and process improvements across