Associate Aseptic Manager

The Associate Aseptic Manager is responsible for driving the manufacturing floor activities, including solution/equipment preparation and aseptic filtration/filling activities. They partner with aseptic/compounding floor supervisors and technicians in the compounding, equipment preparation, and filling of sterile liquids for development and commercial distribution. This role serves as a key liaison between the Aseptic Operations Manager and the floor, ensuring all business challenges and expectations are communicated, understood and met by the production team.

Personnel in this position have complete ownership of the compounding, equipment prep, and filling areas with guidance from the aseptic operations manager and are responsible for understanding the full cGMP framework established at the site, including product development approach, contamination control strategy, media fill program, equipment train, technician qualification and OJT program for the associated governing areas.

• Interface with the FDA during site audits.
• Evaluate market demand and make Cap Ex recommendations supporting the process from vendor selection through commissioning.
• Develop, revise and approve CGMP framework documents, including protocols, SOPs, BMRs, risk assessments and summary reports.
• Identify and implement operational optimizations of equipment via machine recipe parameter adjustments, including timers, counters and cams.
• Lead daily meetings to communicate daily activities and production needs.
• Communicate effectively with area leadership and cross‑functional departments (maintenance, QC microbiology, QC chemistry, IPQA) to align production needs and ensure timely completion of the production schedule.
• Identify deviations in real time, document write‑ups of issues and investigations in the QMS, taking guidance from IPQA, QEM and production leadership.
• Maintain mastery of all aseptic processing concepts for all applicable processes, including compounding/filtration, equipment and product sterilization, and product filling activities in graded rooms and the aseptic corridor.
• Possess a competitive, detail‑oriented production mentality and strive for perfection.
• Think creatively within the CGMP framework to overcome challenges and present viable solutions.
• Document batch statistics within SAP.
• Create URS documents.
• Lead Risk Assessment (FMEA, HACCP).
• Support cost‑evaluation activities.
• Support the cost and financing review of new equipment and vendor solutions.
• Drive continuous improvement initiatives and operational excellence across the aseptic area.

• Bachelor’s degree required.
• 10–12 years of CGMP/aseptic operations experience.
• In‑depth knowledge of FDA/CGMP regulations, mechanical aptitude and process subject‑matter expertise.
• Strong communication, leadership, and problem‑solving skills.