Associate Principal Scientist, Engineering
Core
Lead technical process leadership and laboratory capabilities for late-stage and commercial drug product processes for biologics and combination products.
Role type
Senior IC Associate Principal Scientist (Biologics Commercialization)
Builds
Sterile drug products and biologics combination products for commercial launch
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biologics process development, Scale-up, Technology transfer, Process validation, Regulatory submissions (CMC), Sterile fill-finish operations, Process characterization, DOE design, Quality by Design (QbD), cGMP compliance
Preferred skills
Potent product manufacturing, Late-stage commercialization, Statistical process control (SPC), Multivariate analysis (MVA), Process analytical technologies (PAT), Digital applications (3-D printing)
Technologies
None explicitly listed as tools/frameworks
Responsibilities
Lead cross-functional working groups through filing and PPQ, Drive strategic initiatives for efficient commercialization, Provide mentorship and technical oversight, Develop process and product development plans, Design and execute commercialization studies and validation, Establish scale-down models and platform engineering, Innovate best practices for tech transfer and control strategy, Influence CMC regulatory strategy and author submissions
Seniority
Senior, hands-on IC with mentorship responsibilities