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Front Line Manufacturing Manager (Downstream) - Night Shift

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Amgen

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Location:
United States , Holly Springs

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Category:

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Contract Type:
Not provided

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Salary:

111714.00 - 139899.00 USD / Year

Job Description:

Be part of Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleXBatch facility combines the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleXBatch facility not only features the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it also integrates sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. This is a vital and dynamic role as a non-shift front line manager in manufacturing. The working schedule is based on a day or night shift (12-hour) rotation. The essential position, which supports our critical 24/7 manufacturing operations, works a 12-hour 2-2-3 schedule from 5:45pm to 6:15am.

Job Responsibility:

  • Oversee teams of manufacturing associates responsible for the manufacture of GMP drug substances
  • Champion a safe and compliant production environment
  • Imbed Lean and continuous improvement principles onto the manufacturing floor
  • Oversee teams in technical, on the floor operations in a biotechnology production operation
  • Support the development of staff through coaching, hiring, and mentorship
  • Assist in defining area objectives, identifying improvement opportunities, and leading change efforts
  • Ensure safe working environment
  • Ensure Amgen policies are followed, including cGMP and CFR compliance
  • Evaluate current operating procedures and recommend changes to management to optimize production
  • Assure all corporate change control procedures are followed
  • 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
  • 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

Additional Information:

Job Posted:
March 22, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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