Assoc. Dir., Engineering
Core
Lead technical operations for external manufacturing of large molecule drug substances, acting as the primary interface with external partners to ensure process viability, compliance, and successful commercialization.
Role type
Senior IC technical operations lead (biologics manufacturing)
Builds
External manufacturing network capabilities for large molecule drug substances
Domain
Biopharmaceuticals / Large Molecule Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Technical leadership, Technical transfer, Process optimization, Risk assessment, Validation strategies, Regulatory compliance, Root cause analysis, Change control, Manufacturing scale-up, Quality systems
Preferred skills
mAb DS production, Conjugation processes, Lean Manufacturing, Six Sigma, Project management, Global regulatory knowledge
Technologies
None explicitly listed
Responsibilities
Lead technical issues between operations and external partners, Execute technical due diligence and risk assessments, Manage complex investigations and process change reviews, Drive continuous process verification and performance monitoring, Provide manufacturing process support and capacity optimization guidance
Seniority
Senior, hands-on IC
