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Front Line Manufacturing Manager (Bulk Drug Substance - Downstream) - Night Shift

United States, Holly Springs Employment contract 106148.00 - 143612.00 USD / Year · Job Posted June 14, 2026
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Job Responsibility

  • Ensure safe working environment
  • Ensure Amgen policies are followed, including cGMP and CFR (Code of Federal Regulations) compliance of assigned areas
  • Evaluate current operating procedures and recommend changes to management to optimize production
  • Assure all corporate change control procedures are followed, and Regulatory and QA are notified prior to the changes
  • Interact with regulatory agencies as needed
  • Assure proper gowning and aseptic techniques are followed
  • Engage staff and build relationships of trust and respect while driving team performance and continuous improvement
  • Recruit, train, evaluate, coach and develop staff
  • Mentor and coach staff members to live by the Amgen Values
  • Develop and implement trainings plans and programs, to ensure staff are prepared and compliant
  • Ensure adherence to production schedule and maintenance activities
  • Interacts with management in optimizing organizational structure and responsibilities
  • Ensure plant safety through auditing, evaluations, and cross functional walks
  • Ensure gowning and aseptic techniques training programs are maintained
  • Demonstrate technical mastery of manufacturing processes
  • Collaborate with cross-functional teams (i.e., QA/QC, F&E, PPIC, Mfg, PD, Regulatory, etc.) in completing production activities
  • Develop, implement and assess CAPAs and solutions to complex problems
  • Responsible for elevating and resolving problems during daily operations
  • Oversees set up, execution, and completion of critical manufacturing processes/tasks
  • Interacts with management in planning, developing and maintaining budget
  • Assist in developing and maintaining department goals

Requirements

  • Doctorate degree OR Master’s degree and 3 years of Manufacturing or Operations experience OR Bachelor’s degree and 5 years of Manufacturing or Operations experience OR Associate’s degree and 10 years of Manufacturing or Operations experience OR High school diploma / GED and 12 years of Manufacturing or Operations experience
  • Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Nice to have

  • Bachelor’s degree in Life Sciences or Engineering
  • Demonstrated strong leadership skills and technical understanding of biotechnology production operations
  • Experience in biotechnology or pharmaceutical plant start up
  • Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
  • Previous knowledge and experience within a cGMP environment
  • 5+ years process experience in a cGMP manufacturing facility
  • 3+ years of experience in a production Area Lead, Specialist or Manager role
  • Strong leadership and teambuilding skills (coaching, mentoring, counseling)
  • Experience with performance management including performance reviews
  • Conflict Resolution, analytical problem solving, and project management skills
  • Thorough understanding of regulatory requirements
  • Excellent verbal and written communication (technical) skills
  • Excellent computer skills with Microsoft, EBR/MES, Delta V, Electronic quality systems

What we offer

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible

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