Principal Engineer
Core
Lead the development, characterization, and technology leadership of aseptic fill/finish operations (filling, lyophilization, visual inspection) and mature platform ecosystems for late-stage biologic drug products.
Role type
Principal Engineer (Biopharmaceutical Manufacturing & Process Development)
Builds
Aseptic manufacturing platforms, standardized process tools, and global technology transfer capabilities for biologic modalities.
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
Aseptic fill/finish process design, Lyophilization technology, Visual inspection systems, Process characterization, Statistical analysis (JMP, Minitab), In silico modeling, Technical transfer strategy, Regulatory compliance (FDA/EU GMP), Cross-functional leadership, Data-driven decision making
Preferred skills
AI/GenAI for automation, Digital process control systems, Recipe development, Equipment design and implementation, SPC, Design of Experiments (DoE), New product development
Technologies
JMP, Minitab, AI/GenAI tools, Digital process control systems, In silico modeling platforms
Responsibilities
Lead design and execution of process development for aseptic filling, lyophilization, and visual inspection; Develop and standardize tools to improve business-process efficiency and harmonization; Partner with unit operation owners to advance characterization and recipe development; Collaborate across the drug product manufacturing network to execute technology transfers; Analyze data using advanced statistical techniques; Author regulatory sections supporting IND and marketing application submissions; Provide progress reports and presentations to management.
Seniority
Principal, strategic leadership with hands-on technical execution
