Senior Associate Manufacturing - Training

Career Category

Manufacturing

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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 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.

Senior Associate Manufacturing - Training

What you will do

Let’s do this. Let’s change the world. 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. We are looking for a talented Manufacturing Specialist to help deliver opportunities for reliability, efficiency, agility and differentiation for the ANC Manufacturing plant.

This individual contributor position reports into the Senior Manager of the Investigation and Training team and interacts broadly across the site to implement key training and (HOP) deliverables, quality initiatives. This role will focus on supporting manufacturing training on and off the floor and supporting investigations when necessary. The flexibility to support all four shifts covering 24/7 operations is a requirement.

• Supporting the development and execution of the manufacturing training strategy, ensuring operational readiness and time to contribution.
• Providing training expertise for MFG area of responsibility (i.e. cell culture, purification, solution prep).
• 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 specialists 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 operators 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator we seek has a biologics Drug Substance manufacturing and investigations background with strong cross-functional project management and communication skills as well as the below qualifications.

Basic Qualifications:

• High School diploma / GED and 4 years of Engineering or Operations experience OR
• Associate’s degree and 2 years of Engineering or Operations experience OR
• Bachelor’s degree and 6 months of Engineering or Operations experience OR
• Master’s degree

Preferred Qualifications:

• 5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressiv