Associate Director, CMC Technology Delivery
Core
Lead digital enablement and transformation of end-to-end Chemistry, Manufacturing and Controls (CMC) operations to scale biopharmaceutical manufacturing with agility and compliance.
Role type
Senior IC Associate Director, CMC Technology Delivery
Builds
Scalable, compliant, and efficient digital CMC solutions for starting material, drug substance, and drug product processes from preclinical to commercial launch.
Domain
Biopharmaceuticals / Life Sciences / CMC / Digital Transformation
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
CMC/Process Engineering expertise, IT solution roadmap execution, digital/AI/ML implementation, data governance and stewardship, GxP and FDA 21 CFR compliance, SDLC management, cross-functional team leadership, system integration (API/EDI), stakeholder management
Preferred skills
Master's/MBA/PhD, Agile/Scrum methodology, emerging AI/data capabilities (data lakehouse, knowledge graphs, LLMs)
Technologies
Empower, SoftMax Pro, Emerson Process Knowledge Management, QbDVision, JMP, Minitab, R, Python, SIMCA, SEEQ, Jira
Responsibilities
Define and execute IT solutions roadmap aligned with business priorities; oversee implementation of digital CMC solutions from DC declaration to NDA filing; drive digital/AI/ML capabilities for regulatory authoring and tech transfer; enable structuring and standardizing process recipe data; partner to develop data assets for CMC statistics; own end-to-end accountability for CMC application lifecycle; ensure systems meet GxP and data integrity requirements; lead and mentor cross-functional teams.
Seniority
Senior, hands-on IC with leadership responsibilities