Manufacturing Associate II

Role: Manufacturing Associate II in DP Operations, responsible for routine aseptic and downstream unit operations in a cGMP biopharma setting. Objectives include ensuring operational efficiency, material readiness, compliance with SOPs, and accurate documentation. Core responsibilities encompass formulation, sterile filtration, vial/syringe filling, visual inspection, equipment checks, and deviation management, supporting continuous improvement within a sterile manufacturing environment. Qualifications: Associate or Bachelor’s in a scientific discipline or equivalent experience; 2-4 years GMP manufacturing preferred, with training available for entry-level candidates. Skills include gowning, cleanroom work, equipment handling, and basic computer literacy; must pass a vision acuity test. Experience in biologics or cell/gene therapy manufacturing is advantageous. The role demands working a 12-hour night shift onsite, with flexibility for overtime and cross-training. High-value specifics: biologics manufacturing, aseptic fill/finish, cGMP compliance, validation, and cross-functional collaboration with QA, QC, Facilities, and Supply Chain teams. The position supports operations critical to the production of therapeutic biologics, emphasizing safety, documentation accuracy, and team collaboration within a fast-paced, regulated environment.