Senior Consultant – Commercial Lyophilization & Sterile Fill-Finish Operations

Senior Consultant – Commercial Lyophilization & Sterile Fill-Finish Operations

Location:San Diego, CA preferred (or surrounding Southern California area) | Hybrid
Length of Assignment:6 Months
Employment Type:Contract, with potential for
contract to hire
based on performance and business needs

We are seeking a highly experienced consultant with deep expertise in
commercial lyophilization (freeze drying) and sterile fill-finish manufacturing operations
to support a growing pharmaceutical manufacturing organization. This individual will provide hands‑on technical and operational leadership, helping optimize commercial production activities, troubleshoot manufacturing challenges, and support strategic operational initiatives.

The ideal candidate is a seasoned manufacturing professional who began their career in engineering or technical operations and advanced into leadership roles through extensive hands‑on experience in commercial manufacturing environments.

• Serve as a subject matter expert for commercial lyophilization and sterile fill-finish operations.
• Provide technical guidance and operational support for manufacturing processes and production activities.
• Identify and resolve production challenges, process bottlenecks, and operational inefficiencies.
• Support manufacturing readiness, process optimization, and continuous improvement initiatives.
• Advise leadership on best practices for commercial-scale aseptic manufacturing operations.
• Collaborate with Engineering, Quality, Validation, Manufacturing, and Supply Chain teams to ensure compliant and efficient production.
• Mentor manufacturing personnel and provide hands‑on troubleshooting support as needed.
• Support operational growth initiatives within a fast‑paced and evolving business environment.

• Extensive commercial experience with
  lyophilization (freeze drying) operations
  .
• Strong background in
  sterile fill finish manufacturing
  and aseptic processing.
• Demonstrated hands‑on expertise supporting all aspects of commercial production operations.
• Engineering, Manufacturing, or related technical background.
• Progressive career growth from technical or engineering roles into manufacturing leadership positions.
• Proven ability to work independently and provide strategic as well as tactical operational guidance.
• Strong troubleshooting, problem‑solving, and decision‑making skills.
• Available to start immediately or in the near term.

• Experience with
  SP Scientific (SP) Lyophilizer systems
  strongly preferred.
• Native or fluent
  Mandarin Chinese
  speaker.
• Experience working in both
  China and the United States
  highly preferred.
• Located in
  San Diego, CA
  or surrounding areas.
• Experience supporting operations within a biotech, pharmaceutical, or CDMO environment.
• Prior experience working with small, growing organizations as a consultant or operational leader.

The successful consultant will combine deep technical knowledge with practical operational leadership experience. This individual is hands‑on, results‑oriented, and thrives in entrepreneurial environments where speed, flexibility, and execution are critical. They possess a start‑up mindset, a strong sense of urgency, and a proven track record of driving manufacturing success in commercial sterile manufacturing operations.