Technical Services Lead
Core
Lead the design, development, transfer, and optimization of aseptic pharmaceutical manufacturing processes for a new cartridge-filling product line, ensuring compliance with cGMP and global regulatory expectations.
Role type
Senior IC pharmaceutical process engineering lead (sterile injectables)
Builds
Aseptic pharmaceutical manufacturing processes and sterile drug products
Domain
Healthcare / Pharmaceutical manufacturing (sterile injectables)
Required skills
Aseptic processing, Process validation (PPQ), Scale-up, DOE, SPC, Process modeling, CPP/CQA definition, Risk assessment (FMEA, Ishikawa), Root cause analysis, Cross-functional leadership
Preferred skills
Project Management certification, Minitab proficiency
Technologies
Minitab
Responsibilities
Lead process validation (PPQ) and ongoing process verification for sterile drug products; Define critical process parameters (CPPs) and critical quality attributes (CQAs); Lead design, development, and optimization of aseptic manufacturing processes; Initiate and lead process risk assessments and implement mitigation strategies; Analyze process data to identify trends and improve yield; Support investigations, root cause analyses, and CAPA implementation; Lead technical aspects of scale-up, technology transfer, and commercialization.
Seniority
Senior, hands-on IC