Principal Scientist, Drug Product Sterile Solutions
Core
Lead scientific work to develop safe, stable, and manufacturable sterile drug product solutions, including mAbs and oligonucleotides.
Role type
Principal Scientist, Drug Product Formulation
Builds
Sterile drug products and complex biologics for patient use
Domain
Biopharmaceuticals / Sterile Solutions
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Formulation and process development for sterile/complex products, Stability and compatibility study design, Physicochemical and analytical result interpretation, Technical report and regulatory documentation authoring, Data analysis, Mentorship and data quality review
Preferred skills
Biologics and oligonucleotides experience, Container-closure integrity assessment, Technology transfer and scale-up, Statistical design of experiments (DOE), Technical risk assessment, Regulatory submission contribution
Technologies
mAbs, oligonucleotides, container-closure systems
Responsibilities
Design and execute formulation and process development studies, Interpret experimental results and provide recommendations, Lead stability and compatibility assessments, Prepare technical reports and regulatory documentation, Support scale-up and technology transfer, Mentor colleagues and improve lab practices
Seniority
Principal, hands-on IC with strategic influence
