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

• Ensure safe working environment
• Ensure Amgen policies are followed, including cGMP and CFR 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 training 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 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

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 AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

• 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 team building 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

• 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
• 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