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

Amgen SA

Manager Manufacturing(Downstream)- Day Shift Let’s do this. Let’s change the world. In these vital and dynamic roles you will be 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 5:45 am to 6:15 pm. As a manufacturing leader you will oversee teams of manufacturing associates with differing levels of experience who will be responsible for the manufacture of GMP drug substances. Through structured on‑floor presence, you will champion a safe and compliant production environment. As an active participant and role model in a Lean and continuous improvement culture, the manager will embed these principles onto the manufacturing floor. Through your leadership, you will oversee teams in technical, on‑floor operations in a biotechnology production operation. In addition, you will support the development of your staff through coaching, hiring, and mentorship. Font‑line Manager will assist in defining area objectives, identifying improvement opportunities, and leading change efforts; effectively directing their team and delivering short‑ and long‑term Amgen Operational goals. Compliance 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 Staff Supervision 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 Process/Equipment/Facilities 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 Administrative Interact with management in planning, developing and maintaining budget Assist in developing and maintaining department goals Basic Qualifications 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 Preferred Qualifications 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 Benefits and Compensation The annual base salary range for this opportunity in the U.S. is provided below. In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: 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 #J-18808-Ljbffr Amgen SA

Vacancy posted 23 hours ago
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