Director, Biologics Process Optimization Leader

4 weeks ago


Waldorf, Maryland, United States Catalent Inc Full time

Director, Biologics Process Optimization Leader

The Director, Biologics Process Optimization Leader is responsible for developing and delivering process optimization across the Biologics network. This includes process simplification, complexity reduction, and introducing Continuous Improvement in development, clinical product, and processes.

The role will work closely with Site General Managers and Site CI Directors within the Biologics network to identify top pain points/complexity within processes and implement network-wide solutions to simplify and standardize processes.

Key Responsibilities:

  • Develop and execute process optimization strategies
  • Work with multiple sites and teams to roll out process simplification and complexity reduction
  • Standardize and re-engineer processes to achieve global scale
  • Identify and implement manual process improvement opportunities for automation
  • Conduct process improvement analysis, including deep dives, root cause analysis, and training
  • Launch Lean in NPI and proactive problem-solving processes using APQP/QBD concepts and tools
  • Support Quality and Continuous Improvement functional teams in building quality right the first time and waste elimination

Requirements:

  • Minimum 12 years of experience in Operations and Continuous Improvement roles in complex manufacturing environments
  • Black Belt, Master Black Belt, or equivalent experience highly preferred
  • 8 years of experience leading cross-functional professionals in a portfolio of projects
  • 5 years of experience in process simplification and standardization
  • Substantial hands-on experience with value stream mapping, QBD, APQP, COPQ reduction, and quality improvement methods
  • Preferred experience working to regulatory standards: FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP), and Good Documentation Procedures (GDP)

About Catalent:

Catalent is a global drug development and delivery leader, committed to preserving and bettering lives. We offer a dynamic, fast-paced work environment, community engagement, and green initiatives. Our benefits include a generous 401k match, paid time off accrual, medical, dental, and vision benefits, and tuition reimbursement.



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