Manager, Aseptic Operations

Glenmark Pharmaceuticals

. Lead production supervisors, team leads, and technicians .

Posted 10/15/2026full-timeMonroe • North Carolina • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in CGMP and aseptic operations, with a strong focus on compliance, equipment optimization, and effective communication with regulatory bodies. Proven ability to lead teams, mentor staff, and manage production processes while maintaining audit readiness.

Highest-signal resume keywords

CGMP ComplianceAseptic TechniqueFDA InterfaceSOP DevelopmentMachine Recipe Adjustments

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Aseptic ProcessingCGMP ProtocolsRisk AssessmentsBatch Record ReviewFMEA LeadershipHACCP Risk AssessmentsMachine Recipe Parameter AdjustmentsSAP Batch Statistics DocumentationURs CreationContamination Control Strategy

Soft Skills

Servant LeadershipMentoringHigh Emotional Intelligence

Certifications & Qualifications

Bachelor Degree

Industry Keywords

Aseptic OperationsProduction SupervisionEquipment CleaningSterile-Liquid ManufacturingContinuous ImprovementQuality Control MicrobiologyQuality Control ChemistryProduction OutputAudit-Ready StateContamination Control

Tech Stack

Tools & technologies

Assembly

About the role

Key responsibilities & impact

Lead production supervisors, team leads, and technicians
Own solution compounding, equipment cleaning, equipment and commodity preparation and sterilization, aseptic filling, classified-area cleaning, and sterile-liquid manufacturing
Serve as liaison between site senior leadership and the production floor
Understand and oversee the site CGMP framework, product development approach, contamination control strategy, media fill program, equipment train, technician qualification, and OJT program
Interface with the FDA during site audits
Evaluate market demand and make CapEx recommendations from vendor selection through commissioning
Develop, revise, and approve CGMP protocols, SOPs, BMRs, risk assessments, and summary reports
Optimize equipment operation through machine recipe parameter adjustments
Lead daily tier meetings and communicate activities and production needs
Coordinate with site leadership, maintenance, QC microbiology, QC chemistry, and IPQA
Identify deviations in real time and manage issue write-ups and QMS investigations
Oversee aseptic cleaning, sterilization preparation, product pathway assembly, sterile filtration, aseptic filling, terminal sterilization, inspection, and packaging
Maintain production areas in an audit-ready state and documentation to CGMP standards
Review, correct, and close area-specific batch records within expected release timeframes
Support technology transfers, continuous improvement, production output, and departmental goals
Provide oversight for other production areas during leadership absences

Requirements

What you’ll need

Bachelor Degree Required
5–8 years of experience in CGMP/Aseptic Operations
Knowledge of FDA, CGMP, mechanical aptitude, and aseptic processes
Expertise in aseptic technique and aseptic processing
Servant leader, mentor, and high emotional intelligence
Ability to interface with the FDA during site audits
Experience with CGMP protocols, SOPs, BMRs, risk assessments, and summary reports
Experience with machine recipe parameter adjustments, including timers, counters, and cams
Experience with SAP batch statistics documentation
Experience creating URSs
Experience leading FMEA and HACCP risk assessments
Experience supporting costing evaluations