Lead, Manufacturing - Large Scale Purification (Days)

Role: Manufacturing Lead overseeing 24/7 cGMP manufacturing operations for biopharmaceutical production, primarily supporting upstream/downstream processes. Responsibilities include executing processing steps, maintaining cGMP documentation, coordinating shift activities, training staff, investigating deviations, and supporting audits. Works closely with shift Supervisors to ensure compliance and efficient resource use. Qualifications: Bachelor's degree in STEM with at least 4 years of experience, or equivalent combination including certifications such as BioWorks; demonstrated leadership in manufacturing environments, cGMP adherence, and aseptic or cleanroom experience. Preferred: purification process expertise, Lean/Six Sigma certifications. High-Value: biologics manufacturing, aseptic processing, downstream purification, cGMP compliance, validation, and batch documentation. Collaboration: reports to Supervisors, supports cross-functional teams. Work setup: day shift (6 AM-6 PM ET) on a 2-2-3 rotation, with on-site requirements.