Senior Associate Manufacturing - Training

Role Summary

Senior Associate Manufacturing - Training at Amgen North Carolina Biologics Drug Substance Manufacturing plant. This role develops and facilitates manufacturing training and the Human and Organizational Performance (HOP) philosophy across the ANC site to deliver reliability, efficiency, agility, and differentiation. It is an individual contributor position reporting to the Senior Manager of the MFG Technical Training team, requiring the flexibility to support all four shifts in a 24/7 operation.

Responsibilities

• 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.
• Using operational Learning Team strategies to promote open collaboration with staff to maximize learning opportunities and investigation findings.
• Supporting annual requalification programs for manufacturing to ensure training compliance.
• Maintaining accurate Training Assignment Profiles and Assignment Vehicles for Manufacturing areas.
• Serving as Learning Management System SME and first point of contact for questions from MFG staff and management about the training program.
• Presenting complex topics to large and small groups at various levels and clearly communicating complex issues.
• Building effective relationships across functions.
• Navigating ambiguity and applying a structured problem-solving approach.

Qualifications

• Required: High school diploma / GED and 10 years of Manufacturing or Operations experience OR Associate’s degree and 8 years of Manufacturing or Operations experience OR Bachelor’s degree and 4 years of Manufacturing or Operations experience OR Master’s degree
• Preferred: 5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
• Preferred: Experience in training development and facilitation
• Preferred: Training content creation expertise in systems
• Preferred: SOP writing & technical writing skills
• Preferred: Experience working in Learning Management Systems
• Preferred: Degree in Science or Engineering
• Preferred: Experience using Quality Management Systems (i.e. Track Wise or Veeva) for Deviation investigations and CAPAs
• Preferred: Demonstrated project management ability
• Preferred: Experience presenting to inspectors during regulatory inspections and internal audits
• Preferred: Excellent written and verbal communication skills
• Preferred: Ability to work in a team matrix environment and build relationships with partners
• Preferred: Strong interpersonal skills

Skills

• Cross-functional project management
• Strong communication skills
• Ability to work in a matrix environment and build relationships with partners
• Structured problem-solving approach

Education

• Required: High school diploma or GED; Associate’s degree; Bachelor’s degree; Master’s degree
• Preferred: Degree in Science or Engineering

Additional Requirements

• Flexibility to support all four shifts covering 24/7 operations