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

Amgen • Holly Springs, NC

10h • Onsite

About The Position

Amgen is seeking a Front Line Manufacturing Manager for their newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility. This facility combines disposable technologies with traditional stainless-steel equipment for maximum flexibility. It features best-in-class drug substance manufacturing technologies with industry 4.0 capabilities and integrates sustainability innovations to reduce carbon and waste, supporting Amgen's goal of being a carbon-neutral company by 2027. The Manager Manufacturing (Downstream) - Night Shift role is a vital and dynamic position supporting critical 24/7 manufacturing operations. The working schedule is a 12-hour, 2-2-3 rotation from 5:45 pm to 6:15 am. This role involves overseeing teams of manufacturing associates in the production of GMP drug substances, championing a safe and compliant production environment, and actively participating in a Lean and continuous improvement culture. The manager will lead teams in technical, on-the-floor operations, support staff development through coaching, hiring, and mentorship, and assist in defining area objectives, identifying improvement opportunities, and leading change efforts to achieve operational 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 Haves

• 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

Responsibilities

• Ensure a 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 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.
• Interact 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.
• Oversee set up, execution, and completion of critical manufacturing processes/tasks.
• Interact with management in planning, developing, and maintaining budget.
• Assist in developing and maintaining department goals.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed