Process Development Associate - Microbiology

Role: Process Development Associate in Microbiology at Amgen, focusing on microbiological method development, optimization, troubleshooting, and validation. Responsibilities include executing laboratory studies such as endotoxin testing, microbial challenge, bacterial retention, and evaluating rapid microbiology methods; analyzing data; supporting protocol and report drafting; and collaborating with QC, Process Development, Manufacturing, and cross-functional teams. Requirements: Bachelor's degree or equivalent experience (4+ years microbiology lab work), strong microbiological technical skills, experience with compendial methods (bioburden, endotoxins, sterility), aseptic techniques, and good documentation. Preferred: hands-on microbiology lab experience, familiarity with regulatory standards (USP, Ph. Eur., CFR), and proficiency with project management tools. High-value specifics: microbiology within biopharma manufacturing, supporting sterile processes, endotoxin and pyrogen testing, and rapid microbiology evaluation. Work setup: not specified, but involves collaboration across functional teams, with emphasis on technical execution and data analysis.