Contract Development Specialist

3 days ago

Thousand Oaks, California, United States Amgen SA Full time
Job Summary

Amgen SA is seeking a highly skilled Contract Development Specialist to provide critical support to our manufacturing operations. As a key member of our team, you will be responsible for driving execution of transactional and tactical tasks to ensure performance excellence across our external manufacturing network.

Key ResponsibilitiesManufacturing Operations

Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting. Own NC Class II/III records, CAPA, CAPA EV, and complex change control records.

Site Performance Monitoring

Report contract site performance metrics to site lead, identify improvement opportunities, and coordinate, issue, and review meeting minutes. Analyze data and metrics to drive continuous improvement and standardization of performance tools.

Project Management and Technology Transfers

Follow-up and track activities in department-wide projects from conception to implementation and close-out. Manage timelines, highlight risks, and coordinate risk management activities.

RequirementsQualifications
  • Bachelor's degree in Business Administration, Engineering, or Science-related field
  • 5+ years of experience in protein, API, DS, DP, or packaging manufacturing environment
  • 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
  • 2+ years of project management experience leading multi-functional and/or multi-location teams
  • 1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
Competencies
  • Demonstrated competencies of lower GCF levels
  • Matrix management and influencing skills
  • Manufacturing and cGMP knowledge/experience
  • Negotiation skills
  • Operational Excellence proficiency and ability to drive continuous improvement
  • Financial knowledge and business acumen
  • Budget management, including purchase orders, financial forecasting, and adhering to financial targets and systems
  • Proficient project management skills
  • Problem-solving and critical thinking
  • Understanding of contractual requirements
  • Technical writing and multi-level communication skills
  • Demonstrated ability to lead effectively in collaborative/team environment
  • Demonstrated ability to take initiative, drive action, and work under minimum supervision

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