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Director of Manufacturing Operations

Company: Ser--n BioScience
Location: Bend
Posted on: September 16, 2022

Job Description:

Ser--n BioScience is seeking a Director of Clinical Operations to oversee daily operations and play an integral role in the growth and sustainability clinical manufacturing operations. The Director ofClinical Operations leads GMP Manufacturing, Supply Chain, Master Production Scheduling, Internal Technology Transfer, Environmental Health and Safety, and Validation Engineering. This role is acc ountable for the safety, quality, delivery, and cost analysis withinClinicalManufacturing Operations. The preferred candidate will showcase a legacy within GMP manufacturing environments, value client satisfaction, and demonstrate strong leadership skills with a proven track record of building and motivating teams. Supervisory Responsibilities

  • Recruits, interviews, hires, and trains new staff -
  • Mentors and supports operations managers
  • Oversees workflow of the clinical operations teams -
  • Integrates with the senior management team to develop and manage personnel -
  • Performs other related duties as assigned -Duties and Responsibilities
    • 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 Ser--n 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 company
    • Builds and develops a committed team to manage all aspects of area of responsibility, including production planning and scheduling,continuousimprovementin productivity, quality, and cost control -
    • Working 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 -Required Skills and Abilities
      • Ten years of experience in a GMP facility or demonstrated equivalence -
      • Have an expert knowledge of theoperational process, SOPs (Standard Operating Procedures), and cGMPs (current GoodManufacturing Processes) and the reason for their existence -
      • Have an expert knowledge of regulations in respect to cGMPs withinClinicaland CommercialOperations -
      • 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 Productionexperience plus 10 years of progressively increasing managerial experience in a production environment is required -Physical Responsibilities
          • Prolonged periods of sitting at a desk and working on a computer -
          • Must be able to lift up to 50 pounds at times -

Keywords: Ser--n BioScience, Bend , Director of Manufacturing Operations, Executive , Bend, Oregon

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