About the role

  • Senior Process Engineer supporting technology transfer and manufacturing at BrainChild Bio. Collaborating with cross-functional teams to optimize processes in cell therapy.

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
  • Specify and/or purchase equipment and interact with Equipment vendors directly.
  • Specify and/or investigate new raw materials and interact with new raw material vendors
  • 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

  • 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
  • Proficiency with investigations, creating protocols, reports, performing data analysis and experience communicating technical messages to teams
  • 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!
  • Must live in the Seattle area

Job title

Senior Process Engineer

Job type

Experience level

Senior

Salary

$120,000 - $135,000 per year

Degree requirement

Bachelor's Degree

Location requirements

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