Senior Associate Manufacturing - Training
On-siteHolly Springs, North Carolina, United States
Job Summary
Develop and facilitate training and Human and Organizational Performance (HOP) philosophy within the Amgen North Carolina Biologics Drug Substance Manufacturing plant. Support manufacturing teams across cell culture, purification, and MFG Services by performing job task analyses to create performance supporting materials and leading new hire orientations. Serve as the Learning Management System SME, present complex topics to various groups, and support investigations and change controls using operational learning strategies. Maintain accurate training assignment profiles and ensure compliance with annual requalification programs. This role requires flexibility to cover all four shifts for 24/7 operations and reports into the Senior Manager of the MFG Technical Training team.
Required Qualifications
- High school diploma / GED and 10 years of Manufacturing or Operations experience
- Associate's degree and 8 years of Manufacturing or Operations experience
- Bachelor's degree and 4 years of Manufacturing or Operations experience
- Master's degree
- The flexibility to support all four shifts covering 24/7 operations
- Biologics Drug Substance manufacturing background
- Investigations background
- Strong cross-functional project management skills
- Communication skills
- Ability to navigate through ambiguity and provide a structured problem-solving approach
- Ability to present complex topics to large and small groups
- Ability to quickly understand and clearly communicate complex issues
- Ability to build effective relationships across functions
- Ability to build relationships with partners
- Strong interpersonal skills
Desired 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
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