Associate Director of Manufacturing, Science and Technology (MSAT)

Company: BrainChild Bio, Inc.
Location: Seattle
Posted on: April 18, 2024

Job Description:

BrainChild Bio is seeking to hire a AssociateDirector of Manufacturing Sciences and Technology (MSAT).This role will grow and lead a Process Engineering Team and be accountable to drive the technology transfer of lentiviral vector and CAR T manufacturing processes from our academic partner organizations to selected CDMOs for clinical manufacturing. This position will also be responsible for Process Ownership. This includes driving and maintaining lifecycle documentation that enables the transition from clinical to commercial. The ideal candidate has previous experience leading high performing cross-functional teams and has deep experience in managing internal and external relationships. Lastly,they have experience leading tech transfers, have high attention to details, and are exceptional problem solvers. BrainChild products represent novel technologies for underserved patient populations, and the candidate for this position should be able to leverage previous complex problem solving without relying on cookie cutter approaches. The ideal candidate has also played key leading roles on IND submissions for cell therapy products and is passionate about completing novel INDs that advance the development of therapies for patients. Responsibilities:

• Accountable for technical transfers of processes and products from BrainChild Bio academic partners and to partner CDMOs for development and clinical manufacturing
• Build a Process Engineering group tasked with supporting process and analytical development as the Process Owner / voice of manufacturing, execution of tech transfers, and continued support of on-going clinical manufacturingEnsure process engineering team is highly functional at pulling and pushing cross-functional collaborations to ensure harmonization of development activities against timelines
• Drive the completion of Process and Product Risk Assessments that will become the basis of product lifecycle documents and characterization efforts
• Collaborate with project management support to maintain project timelines
• Represent technical transfer and manufacturing progress and operations to BrainChild Bio leadership at an executive level - communicating project status and escalating potential issues when necessary
• Ensure the timing and scope of lifecycle documents are right sized and on time for the specific clinical or commercial phase as needed.Qualifications:
  • 10+ years executing or supporting CMC development activities including experience in cell therapy development
  • 5+ years leading process engineering and/or cross functional teamsExperience managing direct reports
  • Excellent facilitation skills and demonstrated aptitude and experience in influencing stakeholders and leaders
  • Must be willing to travel up to 15% of the time in support of tech transfers$140,000 - $160,000 a year
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Keywords: BrainChild Bio, Inc., Shoreline , Associate Director of Manufacturing, Science and Technology (MSAT), Executive , Seattle, Washington