Downstream Manufacturing Associate III

Pay range: 30-40/hr depending on experience Position Overview: The Downstream Manufacturing Associate III (Lead) provides technical leadership and operational coordination for downstream manufacturing activities within a cGMP environment. This role is responsible for leading purification operations, supporting manufacturing readiness, troubleshooting complex process issues, coordinating cross-functional activities, and driving operational excellence initiatives while ensuring successful batch execution. Key Responsibilities Manufacturing Leadership Lead daily downstream manufacturing operations and provide shop-floor technical support. Coordinate execution of manufacturing campaigns and purification schedules. Ensure manufacturing readiness, equipment availability, and material preparedness for batch execution. Serve as the primary technical resource during downstream manufacturing operations. Provide real-time decision support during process execution and batch recovery activities. Downstream Processing Lead all purification operations including Protein A capture, viral inactivation, ion exchange chromatography, UF/DF, viral filtration, and final bulk drug substance processing. Oversee operation and performance of chromatography skids, AKTA systems, BioSC, TFF systems, and filtration equipment. Monitor critical process parameters and ensure adherence to process specifications. Troubleshoot process and equipment issues to maintain operational continuity. Support implementation of process improvements and manufacturing optimization efforts. Documentation & Compliance Lead preparation and revision of: o Standard Operating Procedures (SOPs) o Master Batch Records (MBRs) o Manufacturing Forms and Logbooks o Equipment and Process Documentation Support deviation investigations, CAPAs, change controls, and risk assessments. Ensure continuous inspection readiness and GMP compliance. Participate directly in regulatory inspections and client audits. Support review and approval of manufacturing documentation for batch release readiness. Cross-Functional Coordination Coordinate activities between Manufacturing, QA, QC, MSAT, Validation, Engineering, Facilities, Warehouse, and Supply Chain teams. Support technology transfer projects from process development through GMP manufacturing. Participate in process validation, PPQ campaigns, and commercial manufacturing programs. Lead manufacturing readiness reviews and campaign planning meetings. Drive continuous improvement and operational excellence initiatives. Coaching & Development Train, mentor, and develop Associate I and Associate II personnel. Provide technical coaching and floor-based leadership. Support qualification programs and onboarding activities. Assist supervisors with scheduling, work assignments, and personnel development plans. Qualifications Education & Experience Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 5+ years of relevant biopharmaceutical manufacturing experience. Previous lead operator, project coordination, or team leadership experience preferred. Experience supporting late-stage clinical or commercial biologics manufacturing preferred. Required Skills Advanced expertise in downstream purification operations and biologics manufacturing. Extensive experience with Protein A and polishing chromatography processes. Strong hands-on experience operating AKTA chromatography systems and TFF platforms. Advanced knowledge of viral filtration, UF/DF, and sterile filtration processes. Strong understanding of GMP regulations, manufacturing systems, and documentation requirements. Proven leadership, decision-making, and organizational skills. Excellent troubleshooting and problem-solving capabilities. Ability to effectively coordinate cross-functional manufacturing activities. Preferred Skills Experience supporting: Technology Transfers Process Validation and PPQ Campaigns Commercial Manufacturing Operations Regulatory Inspections and Client Audits CAPA and Deviation Management Continuous Improvement and Lean Manufacturing Initiatives Physical Requirements Ability to stand for extended periods. Ability to bend, reach, and lift up to 50 pounds. Ability to work in cleanroom environments while wearing required PPE. #J-18808-Ljbffr Planet Pharma