Senior Specialist, Operations
Core
Support commissioning, qualification, start-up, and operational readiness of a new small molecule manufacturing facility in Elkton, VA, ensuring safe, compliant, and efficient operations.
Role type
Senior IC manufacturing operations engineer (drug product)
Builds
New small molecule manufacturing facility for patients in the U.S.
Domain
Biopharmaceutical manufacturing / Small molecule production
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Chemical/Pharmaceutical/Biochemical Engineering, Drug Product/SDI manufacturing, GMP compliance, Cross-functional collaboration, Operational improvement, Troubleshooting, Process optimization, Lean principles, Technology transfer
Preferred skills
Greenfield facility start-up, Commissioning/qualification/validation, Lean tools (Kaizen, 5S, Standard Work), Shift coordination, Leadership delegation
Technologies
MPS (Production System), Lean tools, Standard Work
Responsibilities
Support equipment and process start-up, troubleshooting, and optimization; Coordinate improvement activities across the Integrated Product Team; Define and improve operating practices and standard work; Embed best practices across shifts and functions; Act as a delegate for the Production Lead.
Seniority
Senior, hands-on IC
