Director, Operations - API
Core
Lead the Integrated Process Team (IPT) to shape the future operating model, drive site readiness, and ensure safe, compliant API manufacturing operations at a new small molecule facility.
Role type
Director, Operations - API (Strategic Leader & Hands-on IC)
Builds
Small molecule pharmaceutical manufacturing facility and API production value stream
Domain
Biopharmaceuticals / Small molecule API manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing operations)
Required skills
cGMP compliance, operational planning, project leadership, team leadership, financial stewardship, Lean Six Sigma, problem-solving, capacity planning, change management
Preferred skills
Master's degree, small molecule API manufacturing experience, site start-up/ramp-up experience, organizational design, S&OP, inspection readiness
Technologies
None explicitly listed as tools/frameworks
Responsibilities
Lead strategic and tactical planning for site build-out and operational ramp-up; Define organizational structure, culture, and operating rhythms; Ensure safe, compliant, and reliable API operations; Drive continuous improvement and performance metrics; Manage budget and resource allocation; Develop and coach high-performing teams
Seniority
Director, strategic leadership with hands-on operational oversight