Senior Technical Product Lead
Costa Mesa, CA (On-site)
Full-time | Permanent
Base salary: $140,000–$170,000
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).
- 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.
Please apply with an updated copy of your resume to be considered.
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