Senior Associate - Tech Transfers
Core
Manage tech transfer processes for new molecules, developmental studies, and process validations to ensure safe and effective pharmaceutical products.
Role type
Senior Associate, pharmaceutical tech transfer and validation
Builds
Validated manufacturing processes and regulatory submissions for new drug products
Domain
Pharmaceutical manufacturing and quality assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
tech transfer process execution, validation master plan review, troubleshooting validation issues, statistical analysis of testing results, regulatory compliance (FDA), GMP expertise, quality system management, change control management, deviation investigation support
Preferred skills
sterile product validation, medical device experience, regulatory audit support, AI tool utilization for problem solving
Technologies
Global Document Management System, System Application & Products, Quality Tracking System
Responsibilities
Evaluate and approve validation protocols and reports, troubleshoot equipment and process validation issues, conduct statistical analysis for quality investigations, guide writing of validation documents, manage routine quality systems, support regulatory audits and product transfers
Seniority
Mid-Senior level, hands-on IC