Senior​/Technical Product Lead - Costa Mesa, CA

We're supporting a rapidly growing contract manufacturing organization (CMO) specializing in sterile drug product manufacturing in their search for a Senior Technical Product Lead. This position plays a pivotal role in managing client programs from technology transfer through commercial production-driving both technical execution and project leadership across manufacturing operations.

The ideal candidate brings a strong foundation in aseptic processing, GMP compliance, and cross-functional project management, along with the ability to serve as a key technical liaison between internal teams and external partners.

• Lead new product introductions from feasibility and facility fit through full-scale manufacturing.
• Oversee technology transfer activities, ensuring seamless transition from development to GMP operations.
• Translate process development reports into robust manufacturing documentation (batch records, SOPs, etc.).
• Deliver hands-on process training to manufacturing staff.

• Develop and manage timelines and deliverables for clinical and commercial programs.
• Act as the main technical contact for client partners, ensuring clear communication and delivery excellence.
• Lead cross-functional efforts to enhance process efficiency, scheduling, and execution.

• Support investigations, CAPAs, and change control initiatives.
• Partner with Manufacturing and Quality teams to drive operational excellence and continuous improvement initiatives.

• Bachelor's degree in a scientific or engineering discipline (advanced degree preferred).
• 5-8+ years of experience in biotech or pharmaceutical manufacturing.
• Proven background in aseptic operations and sterile drug product manufacturing.
• 5+ years in technical or project leadership within GMP manufacturing or CMO environments.
• Strong knowledge of GMP compliance and validation practices.