GMP Biologics Manufacturing Specialist

Katalyst-Healthcares-; Madison (WI); Sur place; USD 85 000 - 110 000; Plein temps

Résumé du poste

Katalyst-Healthcares- is seeking a Manufacturing Technical Support / Deviations Specialist with extensive GMP biologics experience. You will provide real-time troubleshooting, support deviations and CAPA, draft GMP documents, and analyze data to drive process improvements.

The role involves cross-functional collaboration with Manufacturing, Quality, Process Development, QC, and Engineering, handling tech transfer, scaling, and late-phase manufacturing in a cGMP environment.

Qualifications

• 5+ years of 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.

Responsabilités

• 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.

Connaissances

GMP documentation

Cross-functional collaboration

Technical writing

Problem solving

Data analysis

Microsoft Office

Troubleshooting

Formation

STEM degree (Associate/Bachelor/Master)

Outils

TrackWise

ComplianceWire

Unicorn

Description du poste

Katalyst-Healthcares- is seeking a Manufacturing Technical Support / Deviations Specialist with extensive GMP biologics experience. You will provide real-time troubleshooting, support deviations and CAPA, draft GMP documents, and analyze data to drive process improvements.

The role involves cross-functional collaboration with Manufacturing, Quality, Process Development, QC, and Engineering, handling tech transfer, scaling, and late-phase manufacturing in a cGMP environment.