Senior MSAT Process Engineer - Gene Therapy Secondment(RTP)

AskBio Inc.; EE. UU.; Presencial; USD 120.000 - 170.000; Jornada completa

Descripción de la vacante

AskBio is seeking a Sr. Process Engineer, Manufacturing Science and Technology (MSAT) to support scale-up, technology transfer, and cGMP manufacturing for clinical and commercial programs.

The role involves onboarding clinical programs into the MSAT lab, conducting scale-up runs, and transferring programs to a contract manufacturing facility. Collaboration with internal and external teams is essential to ensure PPQ readiness.

Formación

• Bachelor’s or Master’s degree in a scientific discipline with relevance to biopharmaceutical manufacturing.
• Experience in a biopharmaceutical manufacturing environment and a strong understanding of process development.
• Excellent written and verbal communication skills and ability to interact with internal and external stakeholders.
• Proficiency with Microsoft Office Suite and data analysis tools.

Responsabilidades

• Collaborate with cross-functional teams to transfer small-scale gene therapy processes into MSAT and scale up to cGMP manufacturing.
• Design, execute, analyze and interpret process characterization experiments to define PPQ strategies.
• Develop predictive small-scale models for scale-up.
• Author protocols and reports and maintain organized electronic lab records.
• Communicate results effectively in technical presentations with stakeholders.
• Lead investigations with data-driven root-cause analysis to resolve issues.
• Maintain a clean, organized laboratory and manage scheduling and materials.

Herramientas

JMP software

DOE design of experiments

Descripción del empleo

AskBio is seeking a Sr. Process Engineer, Manufacturing Science and Technology (MSAT) to support scale-up, technology transfer, and cGMP manufacturing for clinical and commercial programs.

The role involves onboarding clinical programs into the MSAT lab, conducting scale-up runs, and transferring programs to a contract manufacturing facility. Collaboration with internal and external teams is essential to ensure PPQ readiness.