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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

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

• 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.