Manager , Aseptic Operations

Glenmark Pharmaceuticals • Monroe, NC

9d

About The Position

The Aseptic Manufacturing Manager leads production supervisors, team leads, and technicians responsible for solution compounding; equipment cleaning, preparation, and sterilization; aseptic filling; classified-area cleaning; and manufacturing sterile liquids for development and commercial distribution. The manager serves as a liaison between site Senior Leadership and the production floor, ensuring business challenges, expectations, and production needs are communicated and addressed.

The position requires broad understanding of the site’s CGMP framework, product development approach, contamination control strategy, media fill program, equipment train, technician qualification, and on-the-job training program. The manager is an aseptic technique and aseptic process subject matter expert, interfaces with the FDA during site audits, and maintains production areas in an audit-ready state. The role also supports capital expenditure evaluations, process optimization, documentation, risk assessments, production scheduling, and collaboration with cross-functional groups to meet production demands and quality standards.

Requirements

• Bachelor’s degree required.
• 5–8 years of experience in CGMP and aseptic operations.
• Knowledge of FDA requirements and CGMP.
• Mechanical aptitude.
• Aseptic process subject matter expertise.
• Servant leadership, mentoring ability, and high emotional intelligence.

Responsibilities

• Lead production supervisors, team leads, and technicians across aseptic manufacturing operations.
• Oversee solution compounding, equipment cleaning and preparation, equipment and commodity sterilization, aseptic filling, classified-area cleaning, and sterile-liquid manufacturing.
• Serve as liaison between site Senior Leadership and the production floor.
• Review, correct, and close out area-specific batch records within the expected release timeframe.
• Maintain documentation and functional work areas in accordance with CGMP standards.
• Communicate with area leadership and cross-functional departments to align production needs and complete production schedules.
• Assess production challenges, recommend solutions, and seek cross-functional support when appropriate.
• Act as an aseptic technique and aseptic process subject matter expert and interface with the FDA during site audits.
• Evaluate market demand and make capital expenditure recommendations, supporting the process from vendor selection through commissioning.
• Develop, revise, and approve CGMP documentation, including protocols, SOPs, batch manufacturing records, risk assessments, and summary reports.
• Optimize equipment operations by adjusting machine recipe parameters, including timers, counters, and cams.
• Lead daily tier meetings to communicate activities and production requirements.
• Identify deviations in real time, document issues, and conduct investigations in the QMS with guidance from IPQA, QEM, and production leadership.
• Apply aseptic processing concepts and steps, including aseptic cleaning, equipment preparation for sterilization, product pathway assembly, sterile filtration, aseptic filling, terminal sterilization, inspection, and packaging.
• Maintain the production environment in an audit-ready state.
• Document batch statistics in SAP and create user requirement specifications (URS).
• Lead risk assessments, including FMEA and HACCP, and support costing evaluations.
• Provide oversight for other production areas during leadership absences.
• Maintain quality standards and meet day-to-day scheduling needs and departmental goals.
• Lead and develop teams, support parallel technology transfers, and promote ethical, safe, transparent, and compliant work practices.
• Drive production output and continuous improvement while taking ownership of the team, process, and products.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager