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

Amgen • Holly Springs, NC

3h • Onsite

About The Position

Amgen is seeking a Front Line Manufacturing Manager for their Bulk Drug Substance - Downstream operations on the Day Shift. This role is part of Amgen's newest and most advanced drug substance manufacturing plant, the FleX Batch facility, which combines disposable technologies with traditional equipment for maximum flexibility. The facility integrates industry 4.0 capabilities and sustainability innovations, aligning with Amgen's goal to be a carbon-neutral company by 2027. The Manager Manufacturing (Downstream) - Day Shift will be an on-shift front line manager responsible for overseeing teams of manufacturing associates in the production of GMP drug substances. The role emphasizes championing a safe and compliant production environment, actively participating in a Lean and continuous improvement culture, and developing staff through coaching, hiring, and mentorship. The manager will assist in defining area objectives, identifying improvement opportunities, and leading change efforts to achieve Amgen 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, 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

What This Job Offers

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