Senior Process Engineer – Biologics GMP Manufacturing

Abzena Inc.; Bristol Township (Bucks County); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Abzena, at the Bristol, PA site, seeks a Senior Process Engineer to lead advanced process engineering for GMP manufacturing of bioconjugates and biologics. You will drive campaigns, troubleshoot complex processes, and guide technology transfer from development to production.

You will report to the Director of Process Engineering and collaborate with Manufacturing, MSAT, Quality, Facilities, Supply Chain, and Program Management to ensure safe, compliant operations and continuous improvement.

Qualifikationen

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Biotechnology, or related field.
• Minimum 6+ years of experience in biopharmaceutical, biologics, bioconjugation, ADC, or CDMO manufacturing environments.
• Demonstrated experience independently supporting GMP manufacturing operations and leading complex process engineering activities.
• Strong experience with technology transfer, process scale-up, process troubleshooting, data analysis, and process optimization.
• Experience leading process validation support, engineering studies, manufacturing investigations, and change implementation.

Aufgaben

• Provide advanced process engineering support for GMP manufacturing operations including bioconjugation, chromatography, filtration, formulation, and single-use processing systems.
• Provide on-floor technical leadership during manufacturing campaigns, including complex troubleshooting, technical decision support, and issue resolution.
• Partner with Manufacturing and MSAT teams to improve process robustness, throughput, yield, scalability, and execution efficiency.
• Lead technical investigations related to process deviations, operational issues, and adverse process performance trends, including root cause analysis and corrective action development.
• Develop and implement process improvements and engineering solutions that enhance operational reliability and reduce recurring manufacturing risk.

Kenntnisse

Process Engineering

GMP Manufacturing

Technology Transfer

Scale-Up

Troubleshooting

Leadership

Ausbildung

Bachelor's degree in Chemical/Biochemical/Mechanical Engineering or related

Jobbeschreibung

Abzena, at the Bristol, PA site, seeks a Senior Process Engineer to lead advanced process engineering for GMP manufacturing of bioconjugates and biologics. You will drive campaigns, troubleshoot complex processes, and guide technology transfer from development to production.

You will report to the Director of Process Engineering and collaborate with Manufacturing, MSAT, Quality, Facilities, Supply Chain, and Program Management to ensure safe, compliant operations and continuous improvement.