Director of Clinical Operations - GMP Environment

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Located in Bend, OR

Salary: Competitive comp & benefits!

Join one of Central Oregon’s fastest growing companies as the Director of Clinical Operations!

 

Where You Get to Live!

Bend, Oregon is the mountain town that has it all!  Located in the shadows of the Cascade Mountains and surrounded by numerous lakes and rivers, Central Oregon is an outdoor enthusiast’s paradise. Check out the sights and sounds of Bend at: https://vimeo.com/200038114.

 

What You Get to Do!

The Director of Clinical Operations leads GMP Manufacturing, Supply Chain, Master Production Scheduling, Internal Technology Transfer, Environmental Health and Safety, and Validation Engineering.   This role is accountable for the safety, quality, delivery, and cost analysis within Clinical Manufacturing Operations.

  • Directs daily Operations at the Clinical Manufacturing Facility
  • Ensures client project campaigns are delivered on-time and executed to full compliance with global regulatory requirements and client agreements
  • Manages procurement processes and coordinating material, equipment, and resource allocation
  • Oversees GMP Equipment onboarding, qualification, calibration, and maintenance
  • Ensures that the health, safety, and environmental impact policies of the sites are being successfully implemented
  • Optimizes processes to reduce manufacturing costs and maximize GMP production throughput
  • Develops personnel to ensure team cross-functionality, high performance, and long-term retention
  • Develops and implements metrics for constant improvement of Operations and compliance
  • Provides strategic input to support business model and company growth
  • Presents or reports standard information to Leadership team
  • Works with other department staff to identify and implement best-processes
  • Champions and fosters involvement by all levels of the organization of the implementation and maintenance of “Best Practice” processes, enhance teamwork, accountability, and drive a sense of urgency throughout entire company
  • Builds and develops a committed team to manage all aspects of area of responsibility, including production planning and scheduling, continuous improvement in productivity, quality, and cost control
  • Works with the Business Development Team to develop and implement an appropriate process for capacity planning and S&OP
  • Develops and sustains customer relationships through direct interaction, responsiveness, and accountability. Maintains open communication with customers using appropriate tools as necessary
  • Recruits, interviews, hires, and trains new staff
  • Oversees workflow of the clinical operations teams
  • Integrates with the senior management team to develop and manage personnel

 

What You Will Bring:

  • Bachelor’s degree or equivalent knowledge and experience is required
  • Ten years of experience in a GMP facility or demonstrated equivalence
  • Progressively responsible management experience in a GMP environment
  • Have an expert knowledge of the operational process, SOPs (Standard Operating Procedures), and cGMPs (current Good Manufacturing Processes) and the reason for their existence
  • Have an expert knowledge of regulations in respect to cGMPs within Clinical and Commercial Operations
  • Must possess and demonstrate strong motivational and leadership qualities
  • Possess and demonstrate excellent oral and written communication skills
  • Possess excellent proactive problem-solving and analytical skills
  • Possess ability to create a strong, team-based environment
  • Well organized, detail-oriented, possess ability to multi-task
  • Self-motivated, disciplined, focused, work well under pressure and be able to prioritize work
  • Must be dependable and show initiative to improve the overall throughput and financial goals of the organization
  • Must possess the ability to bridge relationships with a variety of individuals and between various departments and levels of the organization
  • Passion for the work you do and the people you do it with!

 

To Apply:  For confidential consideration, please submit resume to karen.turner@expresspros.com

Express Office: Bend
61379 South Highway 97
Bend, OR 97702
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