Al Solutions - San Diego, CA

posted 26 days ago

Full-time - Senior
San Diego, CA
Administrative and Support Services

About the position

The Head of Operations is a key leadership role within a leading Contract Development and Manufacturing Organization (CDMO) located in San Diego, CA. This position oversees all GMP Manufacturing, MSAT (Manufacturing Science and Technology), and Facility & Engineering operations, ensuring the timely delivery of quality materials for clients while maintaining high safety and compliance standards. The role involves both day-to-day operational management and long-term strategic planning as part of the Senior Leadership Team.

Responsibilities

  • Lead the Manufacturing, MSAT, and Facilities & Engineering teams to ensure safe, compliant, and timely delivery of client projects.
  • Oversee the daily operations, defining and implementing operations strategies, processes, and structure.
  • Manage budgeting processes and P&L responsibilities.
  • Monitor operational performance and identify areas for efficiency improvements.
  • Collaborate closely with Supply Chain teams for cost-effective and reliable operations.
  • Partner with Quality teams to ensure adherence to all regulatory and safety standards.
  • Develop and mentor the operations management team, overseeing hiring, training, and performance.
  • Provide regular updates and insights to the Senior Leadership Team.
  • Interface with clients as needed, especially during project execution.
  • Lead site CAPEX governance reviews, manage budgets, and facilitate continuous improvement initiatives using Lean Manufacturing tools.
  • Support the development of strategic plans and communication efforts across the site.
  • Ensure the facility operates to the highest ethical and compliance standards.

Requirements

  • Bachelor's or Master's Degree in Business, Engineering, or a related field.
  • 20+ years of experience in the CDMO or biopharmaceutical industry with a strong focus on cGMP/cGXP environments.
  • At least 15 years of leadership experience, managing large-scale manufacturing operations and technical projects.
  • Proven success in strategic leadership, talent development, and achieving results through teamwork.
  • Expertise in clean room operations, HVAC systems, and familiarity with regulatory and safety standards.
  • Strong verbal and written communication skills, with the ability to present complex information across all levels of the organization.
  • Experience with Operational Excellence and Lean Manufacturing initiatives.

Benefits

  • Opportunity to be part of a cutting-edge CDMO in San Diego.
  • Potential for career advancement in a leadership role.
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