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Director, Manufacturing, Science & Technology
at Renaissance LLC
Lakewood, NJ

Director, Manufacturing, Science & Technology
at Renaissance LLC
Lakewood, NJ

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Description

Renaissance LLC

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.


Overview

The Director of MS&T is responsible for development, scale up, and transfer of production processes into commercial manufacturing. This is a salaried position and exempt from overtime pay.

Responsibilities

• Responsible for developing new production processes including the establishment of batch size, equipment selection, determining critical process parameters, and execution of engineering batches.
• Responsible for tech transfer of existing processes into Manufacturing.
• Responsible for troubleshooting and process improvement for existing commercial products.
• Partners with Product Development, Manufacturing and Validation to ensure a robust New Product Development Lifecycle.
• Ensures that all safety requirements are understood and followed.
• Ensures that all operations are compliant with current Good Manufacturing Practices.
• Ensures that all operations are compliant with DEA and other regulatory requirements.
• Develops future leaders, Supervisors and Managers with a focus on accountability and servant leadership.
• Ensures appropriate training is available to all team members.
• Partners with the Director of Operational Excellence to drive a culture of continuous improvement.
• Partners with the Director of Engineering to develop or acquire new automation and production technology.
• Responsible for ensuring appropriate resources and outstanding execution to achieve business objectives and customer requirements.

Qualifications

• A minimum of 10 years of leadership in Pharmaceutical Development or Tech Transfer.
• Demonstrated expertise in aseptic and injectable manufacturing.
• Excellent coaching and mentoring skills.
• Excellent tech writing and problem solving skills.
• Masters Degree in Engineering, Chemistry, or Pharmaceutical Science; PhD or MBA Preferred.

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