Principal Scientist I, Analytical Development Lead (tLNP CMC)
Core
Lead analytical method development and validation for mRNA-lipid nanoparticle (tLNP) therapeutics, ensuring quality and integrity of drug substance and product.
Role type
Principal Scientist I, Analytical Development Lead (tLNP CMC)
Builds
Robust analytical methodologies for tLNP genetic medicines
Domain
Biopharmaceuticals / mRNA-lipid nanoparticle therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method development for biologics, Capillary electrophoresis, HPLC, QC method qualification/validation, Method transfer, Regulatory submission authoring, Team supervision and mentoring, GxP compliance, Technical problem solving
Preferred skills
Cross-functional collaboration, Strategic scientific innovation, Data interpretation
Technologies
Capillary electrophoresis, HPLC
Responsibilities
Develop/optimize/validate/transfer QC release and stability methods; Provide technical oversight for QC testing at internal and external GMP labs; Plan and review regulatory submission documents and health authority responses; Supervise and mentor a team of scientists; Generate and lead new scientific proposals; Anticipate and evaluate scientific/regulatory advances to update strategies.
Seniority
Principal, hands-on IC with supervisory responsibilities