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Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleXbatch facility will combine the latest in single use technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Job Responsibility:
Supporting the development and execution of the manufacturing training strategy, ensuring operational readiness and efficient time to contribution.
Providing training expertise for MFG area of responsibility (i.e. cell culture, purification, MFG Services).
Leading and organizing MFG New Hire Orientation, ensuring content is up to date and relevant.
Performing Job Task Analysis on the floor to determine where Performance Supporting Materials (SOP updates, videos, one-slide updates etc.) are needed and then creating Performance Supporting Materials to create a best-in-class training program.
Supporting Manufacturing teams during complex investigations and change controls.
Use operational Learning Team strategies to promote open collaboration with staff to maximize learning opportunities and investigation findings.
Support annual requalification programs for manufacturing to ensure training compliance.
Maintain accurate Training Assignment Profiles and Assignment Vehicles for Manufacturing areas.
Serve as Learning Management System SME and first stop for questions from MFG staff and management about the training program.
Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
Build effective relationships across functions.
Navigate through ambiguity and provide a structured problem-solving approach.
Requirements:
High school diploma / GED and 10 years of Manufacturing or Operations experience
Associate’s degree and 8 years of Manufacturing or Operations experience
Bachelor’s degree and 4 years of Manufacturing or Operations experience
Master’s degree
Nice to have:
5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
Experience in training development and facilitation
Training content creation expertise in systems
SOP writing & technical writing skills
Experience working in Learning Management Systems
Degree in Science or Engineering
Experience using Quality Management Systems (i.e. Track Wise or Veeva) for Deviation investigations and CAPAs
Demonstrated project management ability
Experience presenting to inspectors during regulatory inspections and internal audits.
Excellent written and verbal communication skills
Ability to work in a team matrix environment and build relationships with partners
Strong interpersonal skills
What we offer:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible