Senior Scientist, Analytical Development
Core
Develop, optimize, qualify, troubleshoot, and transfer analytical methods for vaccine and biopharmaceutical programs from early development through Phase 1/2 clinical trials.
Role type
Senior Scientist, Analytical Development
Builds
Analytical methods and strategies for viral vaccines and mRNA modalities
Domain
Biopharmaceuticals / Vaccine Development
Required skills
PCR/qPCR/dPCR, sequencing, nucleic acid characterization, viral vaccine modalities, mRNA modalities, GMP compliance, experimental design, data interpretation, scientific writing, mentoring
Preferred skills
Cell-based potency assays, physicochemical analytical methods, emerging analytical technologies
Technologies
PCR, RT-PCR, qPCR, dPCR, Sanger sequencing, next-generation sequencing, electrophoretic methods, chromatographic methods
Responsibilities
Design analytical strategies including method selection, experimental design, controls, and acceptance criteria; Plan and execute testing of development, characterization, and in-process samples; Mentor junior scientists and provide guidance on experimental design and troubleshooting; Collaborate with cross-functional teams including Process Development, Manufacturing, QC, and Regulatory Affairs; Prepare regulatory documentation including SOPs, qualification protocols, and technical summaries; Evaluate emerging analytical technologies and establish new capabilities.