Seeking a Scientist to develop and transfer four UPLC analytical methods for Analytical Development and Quality Control. The role involves quantifying residual process reagents in lentiviral vector Drug Product and in-process samples, ensuring early phase validation and method transfer to QC for GMP lot release testing.
Responsibilities:
Develop UPLC methods for new process reagents
Collaborate with AD and QC on method lifecycle stages
Work with systems engineers on sample submission and reporting workflow
Accurate and compliant recording of experiments in an ELN
Manage and prioritize sample submissions, report data timely
Prepare technical reports and presentations
Requirements:
PhD/MS/BS in Biology, Biochemistry with 3-5 years of relevant experience
Expertise with UPLC systems, Thermo (Chromeleon) preferred
Strong communication skills and ability to work in a multidisciplinary team
Proficiency with UPLC, UV/VIS, Fluorescence detection, and CAD
Self-motivated, organized, capable of working in a fast-paced environment
Ability to meet deadlines and manage multiple projects