Process Engineer

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 to hire a Process Engineer to add to our growing team. This role will provide critical support to technology transfer, process development, and manufacturing activities of BrainChild programs. This will include but not be limited to helping execute successful technology transfers to external CMOs, delivering real time support to manufacturing, including investigational support, in person and remote support to manufacturing, interaction with QA, PD and R&D, and acting as the stakeholder voice of manufacturing operations. The ideal candidate will exhibit a problem-solving mindset, deep curiosity, and an understanding of cell therapy and/or vector manufacturing processes. We are looking for a candidate that has a passion for learning and will build excitement in others about finding solutions and seeking truth. They will bring experience with GMPs, manufacturing operations, batch records and SOPs, change controls and deviations. The candidate will preferably bring experience reviewing and interpreting data and be able to summarize key takeaways. They will have a basic understanding and experience with the CMC drug development lifecycle, process risk assessments and Process Control Strategies. Ideally, they’ve been key members of cross-functional teams and helped drive successful tech transfers and/or process improvement efforts.

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.

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% of the time to support tech transfer activities and ongoing manufacturing