Senior Associate Manufacturing - Technical Training, Upstream Bulk Drug Substance

About the role

Amgen is hiring a Senior Associate Manufacturing - Technical Training for its North Carolina Biologics Drug Substance Manufacturing plant, which will be part of the new FleX batch facility combining single-use technology with stainless steel equipment. The role supports manufacturing training on and off the floor and investigations when needed, reporting to the Senior Manager of the MFG Technical Training team. Working 24/7, the candidate must be able to cover all four shifts.

Key responsibilities

• Support the development and execution of the manufacturing training strategy and the Human and Organizational Performance (HOP) philosophy
• Provide training expertise for the manufacturing area of responsibility (cell culture, purification, MFG services)
• Lead and organize the MFG New Hire Orientation
• Perform job task analysis on the floor and create performance supporting materials such as SOP updates, videos and one-slide summaries
• Support manufacturing teams during complex investigations and change controls, and use Learning Team strategies to share findings
• Support annual requalification programs and maintain Training Assignment Profiles and Assignment Vehicles
• Serve as the Learning Management System subject matter expert and present complex topics to groups

Required profile

• Background in biologics drug substance manufacturing and investigations, with strong cross-functional project management and communication skills
• Qualification: Master's degree, or Bachelor's degree with 6 months of manufacturing/operations experience, or Associate's degree with 2 years, or high school diploma/GED with 4 years
• Preferred: 5+ years of related experience in biotech or pharma, training development and facilitation, SOP and technical writing, LMS experience, aseptic technique and laminar flow hood operation, Quality Management Systems (Track Wise or Veeva) for deviations and CAPAs, presentation experience to inspectors, and project management ability

Required skills

• Learning Management Systems
• Quality Management Systems (Track Wise or Veeva)
• SOP writing and technical writing

What we offer

• Salary range of $86,048 to $116,417 USD
• Health, dental, vision, life and disability insurance, retirement savings plan and flexible spending accounts
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives
• Time-off plans, flexible work models including remote work where possible