Front Line Manufacturing Manager (Upstream) - Night shift

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Front Line Manufacturing Manager (Upstream) - Nights

What you will do

Let’s do this. Let’s change the world. In this vital role you will be an on-shift front line manager in manufacturing, specifically in the area of Upstream. The initial schedule will be Monday-Friday 10-hour days and may include work from home. The schedule will transition to a day or night shift (12-hour rotation) upon completion of startup activities.

As a manufacturing leader, you will supervise a team of 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 reinforce these principles onto the manufacturing floor.

Through your leadership, you will lead all aspects of teams in technical, on-the-floor operations. In addition, you will support the development of your staff through coaching, hiring, and mentorship.

All front-line managers will assist in defining area objectives, identifying improvement opportunities, and leading change efforts; optimally advising their team and delivering on short- and long- term Amgen Operational goals.

Responsibilities

Compliance:

• Ensure safe working environment.
• Ensure cGMP and CFR compliance of operating areas.
• Ensure Amgen policies are followed.
• 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 advised prior to the changes.
• Interact with regulatory agencies as needed.
• Assure proper gowning and aseptic techniques are followed.

Staff Supervision:

• Responsible for staff and team performance.
• Responsible for selection, training, evaluation, staff relations and development of staff.
• Ensure staff members live by the Amgen Values.
• Ensure training programs are maintained.
• Ensure adherence to production schedule and maintenance activities.
• Interacts with management in optimizing organizational structure and responsibilities.
• Ensure plant safety through auditing and evaluations.
• Ensure gowning and aseptic techniques training programs are maintained.

Process/Equipment/Facilities:

• Demonstrate technical proficiency in 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 solutions for complex problems.
• Responsible for resolving problems during production.
• Oversees set up and completion of critical manufacturing processes.

Administrative:

• Interacts with management in planning, developing and maintaining budget.
• Assist in developing and maintaining department goals.
• Other functional responsibilities may be assigned.

What we expect of you

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