Sr Associate Mfg - Nights

Role: Senior Associate Manufacturing (Nights) at Amgen, focusing on inoculation/seeding processes within biologics manufacturing. Responsibilities include leading production operations, ensuring safety and compliance, executing validation protocols, troubleshooting equipment and process issues, drafting and revising controlled documentation, and owning deviations and CAPAs. The role also involves supporting continuous improvement initiatives and collaborating with cross-functional teams such as Quality, Engineering, and Process Development. Qualifications: High school diploma/GED with 4+ years manufacturing experience, or an associate’s degree with 2 years, or a bachelor’s degree with 6 months; relevant experience in biologics or aseptic processing preferred. Skills include knowledge of small-scale bioreactors, CFR/regulatory standards, GMP, and basic troubleshooting on bioreactors and lab equipment. Experience with Delta V, LIMS, and statistical analysis is advantageous. High-value specifics: biologics manufacturing, aseptic processes, GMP, validation, and cross-functional collaboration in a biopharma environment. Work setup: rotating 12-hour night shifts (7PM-7AM), with a 2-6 week initial administrative onboarding period; includes shift differential and premium pay for Sundays.