Process Development Specialist - Lyophilized Injectables
Core
Develop, optimize, and scale-up lyophilization processes for sterile injectable pharmaceutical products from lab to commercial manufacturing.
Role type
Process Development Specialist (Lyophilized Injectables)
Builds
Sterile injectable pharmaceutical products
Domain
Pharmaceutical manufacturing / Biopharmaceuticals
Required skills
Lyophilization cycle development, Scale-up, Technology transfer, GMP compliance, Experimental design, Root cause analysis, Process validation, Quality by Design, Data analysis, Technical documentation
Preferred skills
Formulation development, Risk assessment, Continuous improvement initiatives
Technologies
Freeze-dryers, Process analytical technology (PAT), Experimental design software
Responsibilities
Develop and optimize lyophilization cycles, Evaluate critical process parameters and quality attributes, Support scale-up and technology transfer, Investigate process deviations and support CAPA, Prepare process development documentation and transfer packages, Contribute to Quality by Design and risk assessments.
Seniority
Mid-to-Senior, hands-on IC
