Director, Manufacturing
Core
Develop and execute operational readiness strategy for bioconjugate drug substance manufacturing facilities, ensuring GMP compliance and inspection readiness for clinical and commercial production.
Role type
Director, Manufacturing Operations (Bioconjugates)
Builds
New manufacturing facilities and operational models for bioconjugate drug substances
Domain
Biopharmaceuticals / Bioconjugates / CDMO
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP manufacturing operations, facility design and commissioning, organizational design, workforce planning, technology transfer, risk mitigation, cross-functional leadership, capital project management, process validation, regulatory compliance
Preferred skills
Lean Manufacturing, Six Sigma, automation systems, digital manufacturing platforms, data integrity principles
Responsibilities
Lead operational readiness activities for assigned growth investment projects; Develop and execute operations readiness roadmaps including organizational design and training strategies; Define future manufacturing organization structures and governance models; Serve as primary Operations representative for facility and process design reviews; Partner with Engineering, Quality, and Automation to integrate operational requirements; Establish processes ensuring GMP compliance and inspection readiness; Lead operational planning for technology transfers and commercial launches; Identify and mitigate operational and project risks; Build and lead high-performing manufacturing teams.
Seniority
Director, strategic leadership with hands-on operational oversight
