Technical Lead Sterile Products
Core
Technical expert for sterile manufacturing processes, partnering with CMOs to ensure product quality, process robustness, and operational excellence throughout the product lifecycle.
Role type
Senior IC Technical Lead (Sterile Manufacturing)
Builds
Commercial sterile products (injectables, biologics, medical devices)
Domain
Biopharmaceuticals / Medical Devices / Sterile Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
sterile manufacturing processes, aseptic processing, process validation, lifecycle management, technology transfer, troubleshooting, GMP compliance, cross-functional leadership
Preferred skills
cell culture, fermentation, purification, sterile fill-finish, packaging, cleanroom operations
Technologies
aseptic processing, validation, cleanroom environments
Responsibilities
Serve as technical subject matter expert for sterile manufacturing processes and products; Provide technical stewardship for commercial products and support New Product Introductions (NPI) at CMOs; Lead lifecycle management activities, including process, raw material, and packaging material changes; Drive process improvements focused on quality, yield, efficiency, and cost optimization; Support technology transfers for sterile products, injectable semi-finished products, and medical device assembly and packaging; Lead investigations, troubleshooting activities, and risk assessments related to product and process deviations; Review and approve manufacturing specifications, protocols, reports, and other technical documents.
Seniority
Senior, hands-on IC