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

HOW MIGHT YOU DEFY IMAGINATION? 

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. 

Be part of Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleX Batch facility combines the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch 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. 

Manager Manufacturing (Downstream) - Night Shift

Live 

What you will do 

Let’s do this. Let’s change the world. In these vital and dynamic roles you will be an on-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.

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 the 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 imbed these principles onto the manufacturing floor. 

Through your leadership, you will oversee teams in technical, on the 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 trainings 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 

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 comp