NPI / Digital Specialist

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.

NPI / Digital Specialist

What you will do

In this critical role for the Thousand Oaks Drug Product (DP) facility, - also known as ATO B20 - you will be responsible for the introduction of clinical new products into the manufacturing plant, as well as design electronic batch records supporting these introductions. This “Specialist Manufacturing” role will serve as a New Product Introduction (NPI) Lead and Digital Solutions subject-matter expert within the New Product Introduction, Manufacturing Execution Systems, and Digital team at ATO B20.

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 breakthroughs.
• Leading cross-functional arguments to ensure that the plant is operating according to its long-term strategy.
• 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, on a Right-First-Time basis.
• Proactively leading cross-functional team meetings, to ensure project(s) and other relevant cases implement per schedule.
• Succinctly communicating verbally, in writing, and through presentations to peers and senior leadership team.
• Generate new and maintain existing Digital products used to support plant operations, i.e. Work-Center Team Dashboards, Process Monitoring Reports etc.
• Contribute to Lean Transformation through recording cross-functional metrics and application of continuous improvement tools.
• Engage with the rest of the Amgen network to benchmark, assess differences, and identify path forward toward higher-effectiveness way-of-working.

Additional Responsibilities include:

• Holding supporting functions accountable for delivery of project tasks through documentation of Lessons Learned and presentation to management.
• 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, relevant lifecycle management strategies, and digital solution implementation.
• 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 professional we seek is a self starter with these qualifications.

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 2 years of GMP manufacturing experience

Or

Bachelor’s degree and 4 years of GMP manufacturing experience

Or

Associate’s degree and 8 years of GMP manufacturing experience

Or

High school diploma / GED and 10 years of GMP manufacturing experience

Preferred Qualifications:

• Project Management experience
• Direct and/or indirect people management / leadership experience
• Understanding of Drug Product Formulation and Vial/Syringe Filling operations
• Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices
• Experience with MES, ERP, Tableau, Sma