Senior Associate Manufacturing - Technical Training - Upstream Bulk Drug Substance
Amgen
August 19, 2026
Remote friendly (Holly Springs, NC)
United States
Operations
Senior Associate Manufacturing - Technical Training (Upstream Bulk Drug Substance)
Responsibilities:
- Develop and execute the manufacturing training strategy to ensure operational readiness and efficient time to contribution.
- Provide training expertise for cell culture, purification, and MFG Services.
- Lead and organize MFG New Hire Orientation; keep content current.
- Perform Job Task Analysis to identify needed Performance Supporting Materials (e.g., SOP updates, videos, one-slides) and create best-in-class training.
- Support manufacturing teams during complex investigations and change controls.
- Use Learning Team strategies to promote collaboration and maximize learning from investigations.
- Support annual manufacturing requalification programs to ensure training compliance.
- Maintain Training Assignment Profiles and Assignment Vehicles.
- Serve as Learning Management System SME and first point of contact for training program questions.
- Present complex topics to large and small groups; communicate clearly.
- Build cross-functional relationships.
- Navigate ambiguity with structured problem-solving.
Qualifications:
- Master’s degree OR Bachelor’s degree + 6 months Manufacturing/Operations OR Associate’s degree + 2 years Manufacturing/Operations OR High school/GED + 4 years Manufacturing/Operations.
Preferred:
- 5+ years biotech/pharma manufacturing, process development, or QA; progressively increasing responsibility.
- Training development/facilitation; training content creation; SOP/technical writing.
- Learning Management Systems experience; Science/Engineering degree.
- Aseptic techniques/laminar flow hood experience.
- Quality Management Systems (TrackWise or Veeva) for deviations and CAPAs.
- Project management; present to inspectors/audits.
- Excellent written/verbal communication; team matrix experience; strong interpersonal skills.
Application instructions:
- Apply now via careers.amgen.com.
Responsibilities:
- Develop and execute the manufacturing training strategy to ensure operational readiness and efficient time to contribution.
- Provide training expertise for cell culture, purification, and MFG Services.
- Lead and organize MFG New Hire Orientation; keep content current.
- Perform Job Task Analysis to identify needed Performance Supporting Materials (e.g., SOP updates, videos, one-slides) and create best-in-class training.
- Support manufacturing teams during complex investigations and change controls.
- Use Learning Team strategies to promote collaboration and maximize learning from investigations.
- Support annual manufacturing requalification programs to ensure training compliance.
- Maintain Training Assignment Profiles and Assignment Vehicles.
- Serve as Learning Management System SME and first point of contact for training program questions.
- Present complex topics to large and small groups; communicate clearly.
- Build cross-functional relationships.
- Navigate ambiguity with structured problem-solving.
Qualifications:
- Master’s degree OR Bachelor’s degree + 6 months Manufacturing/Operations OR Associate’s degree + 2 years Manufacturing/Operations OR High school/GED + 4 years Manufacturing/Operations.
Preferred:
- 5+ years biotech/pharma manufacturing, process development, or QA; progressively increasing responsibility.
- Training development/facilitation; training content creation; SOP/technical writing.
- Learning Management Systems experience; Science/Engineering degree.
- Aseptic techniques/laminar flow hood experience.
- Quality Management Systems (TrackWise or Veeva) for deviations and CAPAs.
- Project management; present to inspectors/audits.
- Excellent written/verbal communication; team matrix experience; strong interpersonal skills.
Application instructions:
- Apply now via careers.amgen.com.