Senior Associate Manufacturing - Technical Training - Upstream Bulk Drug Substance

Amgen•Holly Springs, NC

3d•Hybrid

About The Position

Amgen is seeking a Senior Associate Manufacturing - Technical Training - Upstream Bulk Drug Substance for its newest and most advanced drug substance manufacturing plant, the Amgen FleX batch facility. This facility combines the latest in single-use technologies with traditional stainless-steel equipment for maximum flexibility. It will feature best-in-class drug substance manufacturing technologies with industry 4.0 capabilities and integrate sustainability innovations to reduce carbon and waste, aligning with Amgen's plan to be a carbon-neutral company by 2027. This role is a key member of the team developing and facilitating training and the Human and Organizational Performance (HOP) philosophy in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. The position reports into the Senior Manager of the MFG Technical Training team and interacts broadly across the site to implement key training and HOP deliverables and quality initiatives. The role focuses on supporting manufacturing training on and off the floor and assisting with investigations when necessary. Flexibility to support all four shifts covering 24/7 operations is required.

Requirements

Master’s degree OR Bachelor’s degree and 6 months of Manufacturing or Operations experience OR Associate’s degree and 2 years of Manufacturing or Operations experience OR High school diploma / GED and 4 years of Manufacturing or Operations experience
Biologics Drug Substance manufacturing and investigations background
Strong cross-functional project management skills
Strong communication skills

Nice To Haves

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
SOP writing & technical writing skills
Experience working in Learning Management Systems
Degree in Science or Engineering
Experience with Aseptic techniques and laminar flow hood operation
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

Responsibilities

Support the development and execution of the manufacturing training strategy, ensuring operational readiness and efficient time to contribution.
Provide training expertise for MFG areas of responsibility (i.e., cell culture, purification, MFG Services).
Lead and organize MFG New Hire Orientation, ensuring content is up-to-date and relevant.
Perform Job Task Analysis on the floor to determine where Performance Supporting Materials (SOP updates, videos, one-slide updates, etc.) are needed and create these materials to build a best-in-class training program.
Support Manufacturing teams 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 a Learning Management System SME and the first point of contact for questions from MFG staff 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.