Aseptic Manufacturing Manager CGMP Leader SME

Glenmark-Pharmaceuticals; Monroe (NC); On-site; USD 120,000 - 150,000; Full time

Job summary

Glenmark Pharmaceuticals Inc. in North Carolina seeks an experienced Aseptic Manufacturing Manager to lead a team of production supervisors, team leads and technicians responsible for sterile liquids development and distribution.

The role owns aseptic techniques and CGMP compliance, interfaces with site leadership and FDA during audits, and drives process improvements and cost evaluations. Bachelor degree required with 5–8 years CGMP/aseptic operations experience; this full‑time position offers

Qualifications

• Aseptic technique expertise and CGMP compliance knowledge.
• Experience with CGMP processes and aseptic manufacturing.
• Strong leadership and cross-functional collaboration skills.

Responsibilities

• Expert in aseptic technique and aseptic process SME.
• Interfaces with the FDA during site audits.
• Evaluates market demand and makes CapEx recommendations.
• Developing, revising and approving CGMP framework including protocols, SOPs, BMRs and risk assessments.
• Identifies and implements operational optimizations of equipment and processes.
• Leads daily tier meetings to communicate production needs.
• Communicates with area leadership and cross-functional departments to align production needs.
• Identifies deviations and handles investigations in the QMS with guidance.
• Maintains production environment in an audit ready state.
• Documents batch statistics within SAP.
• URS creation and costing evaluation support.
• May oversee other production areas during leadership absences.

Skills

Aseptic technique

CGMP knowledge

Leadership

Interdepartmental collaboration

FDA audits

Education

Bachelor's degree in related field

Tools

SAP

Job description

Glenmark Pharmaceuticals Inc. in North Carolina seeks an experienced Aseptic Manufacturing Manager to lead a team of production supervisors, team leads and technicians responsible for sterile liquids development and distribution.

The role owns aseptic techniques and CGMP compliance, interfaces with site leadership and FDA during audits, and drives process improvements and cost evaluations. Bachelor degree required with 5–8 years CGMP/aseptic operations experience; this full‑time position offers