Senior Associate Manufacturing - Technical Training - Upstream Bulk Drug Substance
Core
Develop and facilitate technical training and Human and Organizational Performance (HOP) philosophy for biologics drug substance manufacturing operations.
Role type
Senior Manufacturing Technical Training Specialist
Builds
Training programs, performance supporting materials, and operational readiness for cell culture and purification processes.
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
Biologics drug substance manufacturing experience, investigations background, cross-functional project management, training development and facilitation, SOP writing, technical writing, Learning Management Systems expertise, aseptic techniques, laminar flow hood operation, Quality Management Systems (Track Wise/Veeva), regulatory inspection presentation.
Preferred skills
5+ years in biotech/pharma manufacturing, science or engineering degree, project management ability, presenting to inspectors, team matrix environment experience.
Technologies
Learning Management Systems, Track Wise, Veeva, single use technologies, stainless-steel equipment.
Responsibilities
Develop and execute manufacturing training strategy, lead new hire orientation, perform job task analysis to create performance supporting materials, support complex investigations and change controls, maintain training assignment profiles, serve as LMS SME, present complex topics to various groups.
Seniority
Senior, hands-on IC