Associate Aseptic Manager

POSITION SUMMARY

The Associate Aseptic Manager is responsible for driving the manufacturing floor activities including but not limited to solution/equipment preparation and aseptic filtration/filling activities. They will partner with the aseptic/compounding floor supervisors and technicians in the compounding, equipment preparation, and filling of sterile liquids for development and commercial distribution. This role is 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. 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. Additional Responsibilities include:

• Interfaces with the FDA during site audits
• Evaluates market demand and makes CapEx recommendation supporting the process from vendor selection through commissioning.
• Developing, revising and approving all manner of CGMP framework including protocols, SOP’s, BMR’s, risk assessments and summary reports.
• Identifies and implements operational optimizations of the equipment via machine recipe parameter adjustment, including timers, counters and cams.
• Leads daily meetings to communicate day’s activities and production needs.
• Communicates effectively with area leadership and cross-functional departments including maintenance, QC microbiology, QC chemistry and IPQA to align production needs and ensure timely completion of production schedule.
• Identifies deviations in real time handling write up of the issue and investigation in the QMS, taking guidance from IPQA, QEM and production leadership.
• Has mastery of all aseptic processing concepts for all applicable processes including compounding/filtration, equipment and product sterilization, and product filling activities in the graded rooms and aseptic corridor.
• Possesses competitive, detailed oriented production mentality and is not satisfied by anything less than perfection.
• Thinks creatively within the bounds of CGMP framework to overcome challenges and brings viable solutions to the table.
• Documents batch statistics within SAP.
• URS creation.
• Leads Risk Assessment (FMEA, HACCP).
• Supports Costing Evaluations.

OVERALL JOB RESPONSIBILITIES

Operations Excellence

• With guidance from the Aseptic Operations Manager, leads the production supervisors, team leads, and floor technicians in the compounding, sterilization, and filling of drug product..

• Serves as Liaison between aseptic operations manager and the Floor.

• Review, correction and close out of area specific batch records as delegated.

• Maintain documentation and functional work areas to CGMP standards.

• Communicates effectively to area leadership and all cross functional groups to ensure completion of production demands.

• Assesses situation and provides accurate recommendations to overcome challenges, reaching out for appropriate cross-functional support when needed.

Innovations

Responsible for maintaining the company’s high standards of quality, to meet the day-to-day scheduling needs and accomplishes the departmental goals

Stakeholder

Consistently operates in an ethical and safe manner; compliant with procedures and policies; builds trust; tells the truth; initiates transparency into problems; communicates issues openly. Builds strong, diverse teams; attracts and retains good people; develops and makes people better; empowers others; flawless execution to support all the multiple technology transfer running parallel

Quality/Output

Continue to drive production and think outside the box to maximize output and try to balance personal life with continue changes on daily tasks requirements.

Ownership

Ownership of the team, process and the products being manufactured. Doing it correctly the first time with pride and quality. Focus on working with your team members on ways to succeed

KNOWLEDGE, SKILLS AND ABILITIES

Education

Bachelor Degree Required

Experience

10 – 12 Years’ experience in CGMP/Aseptic Operations Background

Knowledge & Skills

FDA/CGMP/Mechanical Aptitude/Process SME