Process Engineer: Cell Therapy & Tech Transfer

BrainChild Bio; Seattle (WA); On-site; USD 120,000 - 150,000; Full time

Job summary

BrainChild Bio is seeking a Process Engineer to support technology transfer, process development, and manufacturing activities. You will collaborate with QA, PD and R&D, act as the voice of manufacturing, and assist in real-time and remote support for clinical production.

The ideal candidate has experience with GMPs, batch records, SOPs, change controls and deviations, and understands the CMC lifecycle and risk assessment processes. Travel up to ~15% is expected.

Qualifications

• 4–5+ years in life sciences supporting process development or manufacturing process improvement and support activities, preferably in cell therapy.
• Proficiency with life science data analysis and visualization tools and experience communicating technical messages to teams.
• Ability to travel approximately 15% to support tech transfer activities and ongoing manufacturing.

Responsibilities

• Support clinical manufacturing by leading investigations and troubleshooting activities as needed
• Provide on the floor GMP manufacturing support as needed
• Support process development teams as the voice of manufacturing during clinical product development
• Drive technology transfer of manufacturing processes from development to external CMOs as a key member of cross-functional teams
• Summarize data sets to management in order to ensure process changes/drift is understood
• Drive and Support the effort to create established batch records, for both development and GMP Manufacturing
• Develop and use systems for clinical manufacturing data collection and trending
• Support clinical manufacturing by leading investigations, providing input to change controls, and troubleshooting activities as needed
• Support process risk assessments as needed to drive further characterization studies and/or Process Control Strategy documents.

Skills

GMP manufacturing

Data analysis

Cross-functional collaboration

Technical communication

Job description

BrainChild Bio is seeking a Process Engineer to support technology transfer, process development, and manufacturing activities. You will collaborate with QA, PD and R&D, act as the voice of manufacturing, and assist in real-time and remote support for clinical production.

The ideal candidate has experience with GMPs, batch records, SOPs, change controls and deviations, and understands the CMC lifecycle and risk assessment processes. Travel up to ~15% is expected.