Manager, Fill Finish Technical Operations

Position Summary

This position is responsible for managing the process and providing technical support and guidance for the Fill/Finish teams and projects.

Essential Functions (ES) and Responsibilities

• Establish and maintain quality processes within Fill-Finish Operations
• Develop or revise procedures as needed in conjunction with the Quality Department for filling and finishing. Ensure proper documentation, procedures, batch records, improve quality, and Fill-Finish manufacturing efficiency.
• Establish weekly production schedules to ensure customer orders and product specifications are met.
• Direct Validation efforts, interacting with Quality Control Directors, Technical Services and Quality Assurance.
• Develop more efficient methods for departmental operations.
• Responds to reports from internal/external audits.
• Assign and supervise change controls or deviation reports as needed.
• Review statistical data with Scientific and Technical Operations, based upon trends and development work, modify procedures using the change control and process validation systems for the goal of optimum yields and productivity.
• Assure compliance with GMP including training, documentation and processes.
• Interact with the management of VP of Supply Chain Operations to establish production schedules and protocols, and provide input into new facility design, operation, and upgrades.
• Assist in preparation of Biological License Application for a new product.

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

• Education Requirements: Bachelor’s degree or equivalent level of technical training/service.

• Experience Requirements: 10+ years of related experience with 3+ years in a managerial role or 6+ in a supervisory role. Knowledge of GMP’s and all aseptic filling and finishing equipment. Good interpersonal skills. Intermediate proficiency in quality document systems, word processing and spreadsheet packages.

Preferred Experience

Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations