Process Engineer - Cell Therapy Tech Transfer

BrainChild Bio, Inc.; Seattle, Northern (WA, KY); Hybrid; USD 105,000 - 115,000; Full time

Job summary

BrainChild Bio is seeking a Process Engineer to support technology transfer, process development, and manufacturing for cell therapy programs. This role involves on-site and remote collaboration with QA, PD and R&D, and acting as the stakeholder voice of manufacturing operations.

Qualified candidates bring GMP experience, batch records, SOPs, change controls and deviations, plus data interpretation and a basic understanding of the CMC drug development lifecycle.

Qualifications

• 4–5+ years in life sciences supporting process development or manufacturing
• Proficiency with life science data analysis and visualization tools
• Ability to travel approximately 15% of the time to support tech transfer activities and ongoing manufacturing

Responsibilities

• Lead investigations and troubleshooting on the clinical manufacturing floor
• Provide GMP manufacturing floor support as needed
• Support process development teams as the voice of manufacturing during product development
• Drive technology transfer of manufacturing processes to external CMOs as a key cross-functional member
• Summarize data sets to management to ensure process changes/drift is understood
• Create established batch records for development and GMP manufacturing
• Develop systems for clinical manufacturing data collection and trending
• Lead investigations and contribute to change controls and troubleshooting
• Support risk assessments to drive characterization studies and Process Control Strategy documents

Skills

Life sciences data analysis

Data visualization

Cross-functional communication

Travel readiness

Job description

BrainChild Bio is seeking a Process Engineer to support technology transfer, process development, and manufacturing for cell therapy programs. This role involves on-site and remote collaboration with QA, PD and R&D, and acting as the stakeholder voice of manufacturing operations.

Qualified candidates bring GMP experience, batch records, SOPs, change controls and deviations, plus data interpretation and a basic understanding of the CMC drug development lifecycle.