BrainChild Bio
Senior Process Engineer
Seattle, WA · Senior
Sponsorship not specified$120k-$135kDetected 97 days ago
Data AnalysisProcess ImprovementProcurementGMPProblem Solving
About the role
- BrainChild Bio is seeking to hire a Senior Process Engineer to add to our growing team.
Responsibilities
- Drive technology transfer of manufacturing processes from development to external CMOs as a key member of cross-functional teams, serving as the Process Owner and Equipment Owner
- Support process development teams as the voice of manufacturing during clinical product development
- Drive and Support the effort to create batch records and SOPs, for both process development and GMP Manufacturing
- Support clinical manufacturing through and past tech transfer including on the floor support, leading investigations, supporting deviations and troubleshooting
- Execute or support process risk assessments as needed to drive further tech transfers, Comparability, characterization studies and/or Process Control Strategy documents.
- Build and develop process engineering toolset and best practices for data analysis and communication. Be able to summarize data sets to management
Requirements
- Proficiency with investigations, creating protocols, reports, performing data analysis and experience communicating technical messages to teams
- The ideal candidate will exhibit an understanding of both cell therapy and viral vector processes.
- Minimally, they will have a basic understanding and experience with process lifecycle documents such as QTPP, establishing CQA's, process risk assessments, and Process Control Strategies.
- Experience with comparability strategies / submissions would be beneficial.
- Minimum BS in Bioengineering, Chemical Engineering, Biology, or other related discipline
- 7+ years in life sciences supporting process development or manufacturing process improvement and support activities preferably in cell therapy
- Ability to travel up to 15% of the time to support tech transfer activities
- Ability to be flexible in job responsibilities - come wear a bunch of different hats!
Compensation
- $120k-$135k
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