New Product Introduction Lead

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.

Specialist Manufacturing, New Product Introduction

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for the introduction of new products into the manufacturing plant. This “Specialist Manufacturing” role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital team at ATO B20. The NPI Lead is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital to the impact that ATO B20 with a clinical and commercial product mix has to the Amgen network. This role will function as the site interface between the Amgen network, e.g. Operations Strategy & Business Resilience, Product Delivery Teams, and the B20 site consisting of 5 key functions: Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering. A high degree of interactions and collaboration is required across these groups, and the NPI Lead needs to be able to understand their business and manufacturing processes with enough confidence to drive decision-making and impose timelines.

Responsibilities:

• Working with NPI support groups to develop, maintain, and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project milestones.
• Leading cross-functional business cases to ensure that the plant is operating according to its long-term strategy through a sustainable pace of new commercial product introductions.
• Resolving issues in a timely manner and elevating cross-functional customer concern to various levels of management as appropriate.
• Owning Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur through a Right-First-Time approach.
• Proactively leading cross-functional team meetings, to ensure NPI project(s) and other relevant business cases execute per schedule.
• Succinctly communicating verbally, in writing, and through presentations to peers and senior leadership team.

Additional Responsibilities include:

• Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI project(s).
• Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate.
• Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses.
• Identifying improvement opportunities within the organization and taking proactive steps to build consensus to implement those opportunities.
• Performing purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities as pertaining to NPIs and relevant lifecycle management strategies.
• Reporting on team and plant metrics to ensure visibility to team operations and deliverables.
• Representing the team at plant-wide and network-wide forums, as needed.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 2 years of Engineering, Biology, Chemistry or Life Sciences or GMP manufacturing experience

Or

Bachelor’s degree and 4 years of Engineering, Biology, Chemistry and Life Sciences or GMP manufacturing experience

Or

Associate’s degree and 8 years of Engineering,