Senior/Technical Product Lead - Costa Mesa, CA

Hydrogen Group; California (MO); On-site; USD 150,000 - 210,000; Full time

Job summary

Hydrogen Group is seeking a Senior Technical Product Lead with a strong background in aseptic processing and GMP manufacturing to oversee technology transfer and cross-functional program leadership from development through commercial production.

The role requires 5+ years of technical/leadership experience in biotech/pharma manufacturing, with a proven ability to liaise between internal teams and external partners to drive operational excellence.

Qualifications

• Bachelor's degree in a scientific or engineering field; advanced degree preferred.
• 5+ years in biotech/pharma manufacturing.
• Aseptic operations and sterile drug product manufacturing expertise.
• 5+ years in technical or project leadership within GMP environments.
• Strong GMP compliance and validation knowledge.

Responsibilities

• Lead new product introductions from feasibility through full-scale manufacturing.
• Oversee technology transfer from development to GMP operations.
• Translate development reports into 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 main technical contact for client partners; ensure 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.

Skills

Aseptic processing

GMP compliance

Cross-functional project management

Technical leadership

Client liaison

Education

Bachelor's degree in science or engineering

Job description

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.

Key Responsibilities

Program Leadership & Technology Transfer

• 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.

Project Management & Client Engagement

• 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.

Quality & Continuous Improvement

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

Qualifications

• 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.