Specialist Manufacturing New Product Introduction (NPI):Downstream Readiness
$177.65k - $266.48kAmgen Inc
Senior Director role leading enterprise-wide AI process transformation and innovation at a global pharmaceutical company. Responsible for redesigning core processes to embed AI-driven decision-making, scaling adoption across functions, and delivering measurable business value in a regulated environment.
Responsibilities
- Lead NPI coordination across manufacturing, process development, supply chain, planning, and quality teams
- Drive cross-functional meetings to support technology transfer timelines into the biologics facility
- Ensure production documents are accurate and maintain technical accuracy through project participation
- Support manufacturing troubleshooting, problem-solving, and CAPA development to prevent errors
- Champion lean transformation and operational excellence initiatives to drive continuous improvement
Requirements
- Biologics drug substance manufacturing background with cross-functional project management skills
- High school diploma/GED plus 10 years biotechnology operations experience, or equivalent education/experience combination
- GMP manufacturing operations experience
- Technical knowledge of drug substance processing in cell culture or purification technologies
- Ability to organize, analyze, and interpret technical data through trend analysis and modeling
- Lean manufacturing methodologies and operational excellence background
- Excellent cross-functional communication and technical writing skills
Vacancy posted 20 days ago
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