Director of Operations, Clinical Manufacturing

8/12/22

Portland, OR

1791

Director of Operations, Clinical Manufacturing

Reports to: CEO

The Director of 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, cost process within Clinical Manufacturing Operations.

Supervisory Responsibilities:

  • Recruits, interviews, hires, and trains new staff
  • Oversees workflow of the commercial operations teams
  • Integrates with the senior management team to develop and management personnel
  • Performs other related duties as assigned

Duties/Responsibilities:
  • Directing daily Operations at the Clinical Manufacturing Facility
  • Ensuring client project campaigns are delivered on-time and executed to full compliance with global regulatory requirements and client agreements
  • Managing procurement processes and coordinating material, equipment, and resource allocation
  • Overseeing GMP Equipment onboarding, qualification, calibration, and maintenance
  • Ensuring that the health, safety, and environmental impact policies of the sites are being successfully implemented
  • Optimizing processes to reduce manufacturing costs and maximize GMP production throughput
  • Developing personnel to ensure team cross-functionality, high performance, and long-term retention
  • Developing and implementing metrics for constant improvement of Operations and compliance
  • Providing strategic input to support business model and company growth
  • Present or report standard information to Leadership team
  • Work 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 area
  • Builds and develops a committed team to manage all aspects of area of responsibility, including such business processes production planning and scheduling, continuous improvement in productivity, quality, and cost control
  • Working with the Business Development Team, 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

Require Skills/Abilities:

  • Ten years of experience in a GMP facility or demonstrated equivalence
  • 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

Education and Experience:

  • Bachelor’s degree or equivalent knowledge and experience is required
  • GMP Production experience plus 10 years of progressively increasing managerial experience in a production or comparable environment is required

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