Aseptic Manufacturing Manager

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Regular Full-Time Bedford, MA, US

6 days ago Requisition

Salary Range: $ To $ Annually

The Manufacturing Manager, Aseptic Operations leads commercial sterile drug and medical device manufacturing operations across ISO 7 and ISO 5 cleanroom environments, ensuring compliance, product quality, operational efficiency, and on-time customer delivery. In this role, you serve as a subject matter expert in aseptic processing, contamination control, and cleanroom manufacturing operations.

• Leads daily aseptic manufacturing operations, including equipment setup and sterilization, dissolution, bulk preparation, sterile filtration, formulation, aseptic tank-to-tank transfers, and syringe filling activities.
• Ensures all manufacturing processes comply with FDA cGMPs, ISO 13408, EU GMP Annex 1, and applicable international regulatory requirements.
• Provides leadership, coaching, and development for Manufacturing Leads, Manufacturing Specialists, and Manufacturing Technicians to strengthen technical capability and aseptic discipline.
• Optimizes personnel, equipment, and facility utilization to meet production schedules, customer requirements, and operational performance targets.
• Develops and manages departmental operating budgets, analyzes variances, and implements corrective actions to achieve financial objectives.
• Drives continuous improvement initiatives focused on operational efficiency, cost reduction, contamination control, and expansion of aseptic manufacturing capabilities.
• Collaborates cross-functionally with Quality Assurance, Engineering, R&D, Finance, Marketing, and Supply Chain to support manufacturing operations and successful product transfers.
• Supports quality systems activities including deviations, CAPAs, change controls, investigations, and contamination control improvements.
• Ensures accurate execution of manufacturing documentation, material consumption activities, and MRP transactions within ERP systems.
• Interfaces directly with customers, auditors, and regulatory agencies during inspections and plant audits related to aseptic processing operations.
• Oversees external vendors supporting cleanroom gowning, gowning inventory, and cleanroom cleaning services to ensure compliance with contamination control requirements.
• Performs other duties and projects as assigned.

This role has primary responsibility for the manufacture and delivery of sterile drug and medical device products that meet internal and external customer expectations. The position requires strong analytical decision-making skills and the ability to manage complex aseptic manufacturing operations in highly regulated environments. Erroneous or delayed decisions may result in contamination events, operational disruptions, regulatory risk, or significant business impact.

Success in this role requires deep technical expertise in aseptic processing, sound operational judgment, and strong leadership, organizational, interpersonal, and team-building capabilities.

• Bachelor’s degree in Chemical Engineering, Chemistry, Life Sciences, or equivalent relevant experience.
• Minimum of 8 years of experience in cGMP pharmaceutical or medical device manufacturing environments.
• Minimum of 4 years of progressive supervisory or leadership experience.
• Strong knowledge of pharmaceutical and/or medical device GMP requirements in commercial manufacturing operations.
• Demonstrated experience with aseptic processing, including ISO 7/ISO 5 cleanroom operations, sterile filtration, aseptic transfers, and aseptic filling.
• Experience leading teams in regulated manufacturing environments with a focus on quality, compliance, and operational excellence.
• Strong verbal and written communication skills with the ability to effectively collaborate across functions and with external stakeholders.
• Experience using SAP or similar ERP systems for MRP transactions, manufacturing execution, and reporting.
• Strong analytical, organizational, and project…