Responsible for CMC strategy to enable effective lifecycle initiatives for supply continuity, risk management, line extensions & discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product / process knowledge, capability & improvement, tech transfer, and process validation
Aligns with Global Product team on CMC LCM strategy
Drives the link between CMC strategy on the Global Product team and CMC execution on the CMC subteam
Ensure harmonization/ standardization between facilities and best practice sharing
Accountable to guarantee proper yield tracking and to provide accurate yield status and forecast
Drive Yield projects identification, scoping, prioritization, tracking and reporting
Is the overall product / process expert for the product; provides bridges across expertise represented on the CMC team
Accountable for CMC sections of product dossiers
Provide SME expertise of major process and methods investigations
Anforderungen
Degree in engineering or life sciences
Experience operating globally in a matrixed organization highly preferred
Must be self-motivated, have good interpersonal and communication skills, capable of analyzing and solving complex problems through innovative thought and experience, as well as, project management tools.
Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust
Creating the environment that inspires and enables people
Focusing on the few priorities and provide superior results
