Principal Scientist, Engineering - Sterile Drug Product Commercialization, Biologics
Core
Lead technical process leadership and laboratory capabilities for late-stage and commercial drug product processes for biologics, focusing on process scale-up, technology transfer, validation, and regulatory submissions.
Role type
Principal Scientist, Engineering (Biologics Commercialization)
Builds
Sterile biologics drug products (mAbs, ADCs, fusion proteins) for commercial launch
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
Biologics process development, Scale-up, Technology transfer, Process validation, Regulatory submissions (CMC), Sterile fill-finish operations, Process characterization, Quality by Design (QbD), cGMP compliance, Statistical process control (SPC), DOE design
Preferred skills
Potent product operations, Launch commercialization, Analytical methods for biologics, PAT techniques, Data analytics, Computer modeling
Technologies
None explicitly listed beyond general tools implied in skills
Responsibilities
Execute oversight of biologics product/process design, development, and commercial validation; Lead cross-functional working groups through PPQ and launch; Develop process and product development plans; Mentor team members on scientific/technical issues; Author and review regulatory submissions; Drive process optimization and standardized platforms
Seniority
Principal, hands-on IC with strategic guidance