Senior Associate Manufacturing - Technical Training- Upstream Bulk Drug Substance

About the role

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single-use technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will feature best-in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities and integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

In this vital role, you will be a key member of the team that develops and facilitates training and the Human and Organizational Performance (HOP) philosophy in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. This individual contributor position reports to the Senior Manager of the MFG Technical Training team and interacts broadly across the site to implement key training and HOP deliverables, quality initiatives. The flexibility to support all four shifts covering 24/7 operations is a requirement.

Responsibilities

• Support the development and execution of the manufacturing training strategy, ensuring operational readiness and efficient time to contribution.
• Provide training expertise for MFG area of responsibility (i.e., cell culture, purification, MFG Services).
• Lead and organize MFG New Hire Orientation, ensuring content is up to date and relevant.
• Perform Job Task Analysis on the floor to determine where Performance Supporting Materials (SOP updates, videos, one-slide updates, etc.) are needed and then create those materials to build a best-in-class training program.
• Support 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

• Basic Qualifications:
  • Master’s degree, OR
  • Bachelor’s degree and 6 months of Manufacturing or Operations experience, OR
  • Associate’s degree and 2 years of Manufacturing or Operations experience, OR
  • High school diploma / GED and 4 years of Manufacturing or Operations experience.
• Preferred Qualifications:
  • 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 with aseptic techniques and laminar flow hood operation.
  • 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.

Benefits

• Comprehensive employee benefits package, including:
  • Retirement and Savings Plan with generous company contributions.
  • Group medical, dental, and vision coverage.
  • Life and disability insurance.
  • Flexible spending accounts.
• 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.

Pay

The annual salary range for this opportunity in the U.S. is competitive and will be provided upon request.