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Senior Bioprocess Engineer, Downstream Processing (DSP)(m/w/x)
Technical leadership for GMP downstream processing, including chromatography and TFF/UFDF purification. 10+ years biopharmaceutical GMP DSP experience required. Relocation assistance, agile career path.
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Anforderungen
- 10+ years supporting GMP downstream processing in biopharmaceutical manufacturing
- Expertise in chromatography systems, purification, TFF/UFDF, DSP optimization
- Troubleshooting complex GMP process, equipment, and operational issues
- Experience with deviation investigations, root cause analysis, CAPA, change controls, risk assessments, GMP documentation
- Using process/operational data for decision-making and improvements
- Degree in Biotechnology, Chemical/Bioprocess Engineering, Life Sciences, or equivalent experience
- Excellent communication, collaboration, stakeholder management, leading initiatives, mentoring teams
Aufgaben
- Provide technical leadership for downstream processing operations
- Combine hands-on manufacturing support with engineering expertise
- Ensure safe, compliant, and reliable GMP production
- Serve as senior technical expert for downstream processing manufacturing campaigns
- Ensure safe, compliant, and reliable execution of purification operations
- Provide hands-on shop floor support during campaign preparation, execution, and close-out
- Act as escalation point for complex operational challenges
- Lead technical investigations, root cause analyses, CAPAs, and change controls
- Lead risk assessments to resolve process deviations
- Support manufacturing excellence
- Analyze process performance data to identify trends
- Implement solutions to improve plant throughput, process robustness, and equipment reliability
- Implement solutions to improve yields and cycle times
- Provide subject matter expertise in chromatography and resin management
- Provide subject matter expertise in column packing and tangential flow filtration (TFF)
- Provide subject matter expertise in UF/DF operations and bulk drug substance handling
- Provide subject matter expertise in final processing activities
- Partner with Manufacturing, MSAT, QA, QC, Validation, Engineering, and Supply Chain teams
- Support technology transfers and process validation
- Support operational readiness activities
- Drive continuous improvement initiatives
- Mentor junior engineers and manufacturing personnel
- Strengthen technical capability and operational performance
- Strengthen right-first-time execution
Berufserfahrung
Ausbildung
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Benefits
- Relocation assistance
- Accountability
- Continuous improvement
- Drive operational excellence
- Agile career
- Dynamic working culture
- Opportunities to lead cross-functional initiatives
- Work on biopharmaceutical manufacturing processes
- Inclusive and ethical workplace
- Collaboration
- Compensation programs for high performance
- Mentor colleagues
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Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
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