Senior Specialist, Operations
Core
Support commissioning, qualification, start-up, and operational readiness of a new small molecule API manufacturing facility in Elkton, VA, ensuring safe, compliant, and efficient operations.
Role type
Senior IC API Operations Engineer (Manufacturing Start-up)
Builds
Small molecule drug substance (API) manufacturing processes and facility readiness
Domain
Biopharmaceutical manufacturing / Small molecule production
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, process optimization, troubleshooting, technology transfer, lean management, operational excellence, production planning, project manufacturing, data analysis, inventory management
Preferred skills
greenfield facility start-up experience, validation activities, cross-shift coordination, lead/delegate role experience
Technologies
MPS tools, Kaizen, 5S, Standard Work
Responsibilities
Support commissioning, qualification, start-up, and operational readiness activities for the new API Small Molecule facility; Partner with cross-functional teams to support safe, compliant, and effective plant start-up; Provide technical and operational support during equipment and process start-up, troubleshooting, and optimization; Support technology transfer and implementation of commercial manufacturing processes; Help define, implement, and improve operating practices, standard work, procedures, and routines; Coordinate and prioritize improvement activities and key areas of focus within the IPT; Use lean principles to identify and support improvement opportunities; Act as a delegate for the Production Lead when needed.
Seniority
Senior, hands-on IC
