Manufacturing Specialist

Katalyst CRO; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO seeks a Manufacturing Technical Support / Deviations Specialist to join our biologics manufacturing team in Madison, WI. You will provide real-time technical support, lead deviation investigations, CAPAs, change controls and document GMP records to support late-phase and commercial processes.

You will collaborate with Manufacturing, Quality, Process Development, QC, Engineering and cross-functional partners to optimize technology transfer, scale-up, and process improvements while

Qualifications

• 5+ years of relevant experience in biopharmaceutical/biologics manufacturing or technical support.
• STEM degree: Associate's, Bachelor's, or Master's with relevant industry experience.
• Strong experience with GMP documentation, SOPs, batch records, deviations, CAPA, and change controls.
• Experience with process equipment troubleshooting and single-use manufacturing systems.
• Knowledge of upstream/downstream processing and biologics manufacturing.
• Experience with data analysis, statistical techniques, and process trending.
• Ability to use Microsoft Office and manufacturing/compliance systems such as TrackWise, ComplianceWire, or Unicorn.
• Strong communication, problem-solving, technical writing, and cross-functional collaboration skills.

Responsibilities

• Provide real-time technical support and advanced troubleshooting for GMP manufacturing processes.
• Support deviations, investigations, CAPA, and change controls, including root-cause analysis and impact assessment.
• Draft and revise SOPs, batch production records, reports, and other GMP documentation.
• Support process data analysis, trending, technical reports, and client presentations.
• Work cross-functionally on technology transfer, facility fit, process scaling, and process validation.
• Identify opportunities for process and equipment improvements, efficiency gains, and waste reduction.
• Support biologics manufacturing processes including upstream cell culture, downstream purification, chromatography, TFF, buffer preparation, and filtration.
• Troubleshoot manufacturing equipment, including single-use systems, bioreactors, chromatography systems, and filtration equipment.
• Apply GMP, quality risk management, FMEA, and other compliance practices.
• Work in a cleanroom/cGMP manufacturing environment and support late-phase/commercial manufacturing activities.

Skills

GMP documentation

Deviations handling

CAPA

Change controls

Process troubleshooting

Biologics manufacturing

Single-use systems

Data analysis

Cross-functional collaboration

Education

STEM degree

Tools

TrackWise

ComplianceWire

Unicorn

Job description

Summary

Seeking a Manufacturing Technical Support / Deviations Specialist with experience in GMP biologics manufacturing, technical troubleshooting, deviations, CAPA, change controls, and process improvement. The role supports clinical and commercial manufacturing and works closely with Manufacturing, Quality, Process Development, QC, Engineering, and other cross-functional teams.

• Provide real-time technical support and advanced troubleshooting for GMP manufacturing processes.
• Support deviations, investigations, CAPA, and change controls, including root-cause analysis and impact assessment.
• Draft and revise SOPs, batch production records, reports, and other GMP documentation.
• Support process data analysis, trending, technical reports, and client presentations.
• Work cross-functionally on technology transfer, facility fit, process scaling, and process validation.
• Identify opportunities for process and equipment improvements, efficiency gains, and waste reduction.
• Support biologics manufacturing processes including upstream cell culture, downstream purification, chromatography, TFF, buffer preparation, and filtration.
• Troubleshoot manufacturing equipment, including single-use systems, bioreactors, chromatography systems, and filtration equipment.
• Apply GMP, quality risk management, FMEA, and other compliance practices.
• Work in a cleanroom/cGMP manufacturing environment and support late-phase/commercial manufacturing activities.

Roles & Responsibilities

• Provide real-time technical support and advanced troubleshooting for GMP manufacturing processes.
• Support deviations, investigations, CAPA, and change controls, including root-cause analysis and impact assessment.
• Draft and revise SOPs, batch production records, reports, and other GMP documentation.
• Support process data analysis, trending, technical reports, and client presentations.
• Work cross-functionally on technology transfer, facility fit, process scaling, and process validation.
• Identify opportunities for process and equipment improvements, efficiency gains, and waste reduction.
• Support biologics manufacturing processes including upstream cell culture, downstream purification, chromatography, TFF, buffer preparation, and filtration.
• Troubleshoot manufacturing equipment, including single-use systems, bioreactors, chromatography systems, and filtration equipment.
• Apply GMP, quality risk management, FMEA, and other compliance practices.
• Work in a cleanroom/cGMP manufacturing environment and support late-phase/commercial manufacturing activities.

Required Qualifications

• 5+ years of relevant experience in biopharmaceutical/biologics manufacturing or technical support.
• STEM degree: Associate's, Bachelor's, or Master's with relevant industry experience.
• Strong experience with GMP documentation, SOPs, batch records, deviations, CAPA, and change controls.
• Experience with process equipment troubleshooting and single-use manufacturing systems.
• Knowledge of upstream/downstream processing and biologics manufacturing.
• Experience with data analysis, statistical techniques, and process trending.
• Ability to use Microsoft Office and manufacturing/compliance systems such as TrackWise, ComplianceWire, or Unicorn.
• Strong communication, problem-solving, technical writing, and cross-functional collaboration skills.