Process Development Engineer II, Advanced Therapy Project Management (ATPM)
Core
Lead cross-functional technology transfer teams to establish production processes for advanced therapies (AAV, bioconjugates, synthetic chemistry) at CDMOs.
Role type
Senior Process Development Engineer / Project Manager (Advanced Therapy)
Builds
Production processes and manufacturing readiness for advanced therapy programs
Domain
Biopharmaceuticals / Advanced Therapies / CDMO Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Cross-functional team leadership, technology transfer execution, risk mitigation planning, integrated project planning, stakeholder communication, CDMO engagement, process improvement
Preferred skills
CMC development experience, bioconjugation knowledge, gene therapy/AAV expertise
Technologies
None explicitly listed
Responsibilities
Lead cross-functional tech transfer teams to establish production processes at CDMOs; Drive manufacturing start-up readiness by clarifying scope and tracking deliverables; Own communication strategy and operating cadence for assigned programs; Build and maintain integrated plans across development and transfer activities; Anticipate and address risks to manufacturing readiness; Lead technical forums to drive decisions and resolve issues; Partner with procurement, finance, and legal to support CDMO engagement
Seniority
Senior, hands-on IC with strategic ownership
