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Combination Product Service Operations Manager

1 month ago

Fresno, California, United States BD Full time
Job Description

We are seeking a highly skilled Service Operations Manager to join our team at BD. As a key member of our operations team, you will be responsible for overseeing the on-time completion of client projects and ensuring that projects are completed in alignment with our GMP quality system.

The ideal candidate will have experience in laboratory operations or batch production-level project management and a strong understanding of pharmaceutical and biotechnology services. You will be responsible for managing engineering technician staff, collaborating with commercial and technical personnel, and ensuring that company standard operating procedures are being followed.

Key Responsibilities:

  • Lead and manage the site engineering technician staff and project priorities
  • Oversee client projects, communicate project updates to clients/management, and ensure projects are completed in accordance with client expectations and company's standard operating procedures
  • Collaborate with commercial and technical personnel to support the development of proposals/solutions for clients
  • Motivate team, set performance expectations, track performance, provide staff with timely feedback, and report metrics to management as required
  • Conduct, perform, and/or ensure the following:
    • Works with engineering technician staff to author test protocols as required
    • Oversees laboratory data and document review to ensure work is completed in alignment with company procedures and client expectations
    • Authors and reviews test reports as needed
    • Edits, authors SOPs, IQ/OQ/PQ, change control & other technical documentation related to ZebraSci processes and services
    • Manages equipment and staff schedules to maximize efficiency and productivity
    • Ensures that company standard operating procedures are being followed
    • Collaborates with the technical development team to implement new methods and processes to support client projects
    • Analyzes problems, identifies solutions, and implements recommendations as well as manages quality events in collaboration with the quality team
    • Oversees and assists with equipment maintenance schedule including instrument calibrations, performance verification, and IQOQPQ
    • Assists with quality system-related tasks including but not limited to handling and resolution of quality events such as non-conformances, deviations, and CAPAs, including updates to Quality System documents as needed
    • Trains personnel in company policies, quality system, and procedures
    • Maintains a working knowledge of commonly prescribed methods, background information, and troubleshooting strategies
    • Supports client and agency audits and inspections

Requirements:

  • Experience in the pharmaceutical, combination product, or pharmaceutical services industry
  • Experience in laboratory operations or batch production-level project management and PMP certification is preferred
  • Demonstrates excellent interpersonal skills, solid organizational / prioritization skills and a passion for providing excellent service
  • Flexibility and ability to multitask; can work within a fast-moving environment with multiple shifting priorities and demonstrate resourcefulness in setting priorities and guiding investment in people and systems
  • Candidate must be a self-starter that can tackle new challenges that may not have known outcomes while also driving toward clarity and solutions
  • Knowledge and experience with common prescribed methods such as USP, ISO and ASTM procedures
  • Bachelor's, Master's or PhD degree in a science or engineering discipline plus relevant experience related to combination product or medical device manufacturing/production and/or testing

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.