Senior Associate Manufacturing - Training

Senior AssociateManufacturing- Training

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What youwill do

Let’sdo this.Let’schange the world. In this vital role, you will be a key member of the team thatdevelops andfacilitatestrainingand the Human and Organizational Performance(HOP)philosophyin the Amgen North Carolina Biologics Drug Substance Manufacturing plant.We are looking for a talented Manufacturingteam memberto help deliver opportunities for reliability, efficiency,agilityand differentiation for theANCManufacturing plant.

This individual contributor position reports into the Senior Manager of theMFG TechnicalTraining teamand interacts broadly across the site to implement keytrainingand (HOP)deliverables, quality initiatives. This role will focus on supportingmanufacturing training on and off thefloorand supporting investigations whennecessary. The flexibility tosupport all four shifts covering 24/7 operations is a requirement.

• Supportingthe development and execution of themanufacturingtraining strategy,ensuringoperational readinessandefficienttime tocontribution.

• Providing trainingexpertiseforMFGarea 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 Analysison the floortodeterminewherePerformanceSupportingMaterials(SOP updates, videos,one-slide updates etc.)are needed and thencreating Performance Supporting Materials tocreateabest-in-classtrainingprogram.

• Supporting Manufacturingteamsduring complex investigations andchangecontrols.

• Useoperational Learning Team strategies to promote open collaboration with staff to maximizelearningopportunities andinvestigation findings. 

• Support annual requalification programs for manufacturing to ensure training compliance. 

• MaintainaccurateTrainingAssignmentProfilesand Assignment Vehiclesfor Manufacturing areas.

• Serve as Learning Management System SME andfirststop forquestions from MFGstaffand 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.

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Win

What we expectofyou

We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator weseekhas abiologicsDrug Substance manufacturing andinvestigationsbackground with strong cross-functional project management and communication skills as well as the below qualifications. 

Basic Qualifications:

High school diploma / GED and 10 years of Manufacturing or Operations experienceOR

Associate’s degree and 8 years of Manufacturing or Operations experienceOR

Bachelor’s degree and 4 years of Manufacturing or Operations experienceOR

Master’s 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

• Trainingcontentcreationexpertisein systems