Senior Associate Manufacturing - Training at Amgen

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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

Lets do this. Lets 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
• Associates degree and 2 years of Engineering or Operations experience OR
• Bachelors degree and 6 months of Engineering or Operations experience OR
• Masters degree

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 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 you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.