Senior Specialist, External Manufacturing
Core
Lead technical operations and ensure operational excellence for external manufacturing of small molecule drug substances.
Role type
Senior Manager, External Manufacturing Technical Lead
Builds
Commercialized drug substance products via external partner network
Domain
Biopharmaceutical manufacturing (small molecule drug substance)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Drug substance manufacturing, Process development and scale-up, Technical transfer, Validation strategies, Root cause analysis, Risk assessment, Quality systems, Process optimization, Regulatory requirements knowledge, Manufacturing operations
Preferred skills
Project management, Regulatory inspection support, Lean Six Sigma
Technologies
None explicitly listed
Responsibilities
Lead technical interface with external partners, Execute technical due diligence and tech transfers, Support complex investigations, Review process change requests, Drive continuous process verification, Provide manufacturing process support for issue resolution
Seniority
Senior Manager, hands-on leadership
