Assoc. Director of Engineering – Platform Technical Lead: Mechanical Autoinjectors

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.

Assoc. Director of Engineering – Platform Technical Lead: Mechanical Autoinjectors

What you will do

Let’s do this! Let’s change the world! We are currently seeking an Associate Director of Engineering – Platform Technical Lead for our Mechanical Autoinjector Platform. As part of the Combination Product Development (CPD) group, this role will support technical teams in the successful design, testing, - manufacturing and commercial sustainment of mechanical drug delivery devices for Amgen combination products. The Associate Director of Engineering will collaborate with global team members across systems engineering, process engineering, device development, packaging, primary containers, device quality, product delivery teams, and other groups.

In this role, the Associate Director will lead the testing, design transfer, post-market surveillance, and life cycle management of multiple autoinjector device commercialization efforts. This includes overseeing engineering, characterization, and GMP verification testing, while ensuring alignment with project goals and timelines. The position requires close collaboration with suppliers to enable capacity expansions and evaluate new design changes and improvements, and it demands strong technical background in mechanical engineering and functional leadership of technical teams focused on device design, testing, manufacturing, and regulatory compliance.

The role also requires ensuring compliance with regulatory requirements and quality standards for combination product technologies, while driving the continuous improvement of processes, methods, and tools used in the development and life cycle management of mechanical autoinjector devices. The Associate Director will oversee the creation of technical documentation, including test plans, protocols, reports, and regulatory submissions, and ensure alignment of project timelines, resource allocation, and risk management for successful device commercialization. They will also monitor and assess the lifecycle of mechanical autoinjector devices to ensure post-market performance and regulatory compliance.

Furthermore, the Associate Director will play a key role in supplier management, ensuring that quality and technical specifications are met at all stages of product development and supply. They will provide support to the manufacturing network by ensuring efficient production processes and resolving any technical issues that arise during manufacturing. In addition, they will support agency inspections and respond to Regulatory Technical Queries (RTQs), collaborating with regulatory and product teams to ensure timely and accurate responses to inspection findings or queries.

This role requires strong proficiency in technical team management, mechanical design, drug combination product technologies, and regulatory requirements. The successful candidate will be expected to collaborate with vendors and Amgen suppliers to facilitate the accurate planning and execution of design activities.

• Provide leadership, oversight, and overall representation to Amgen’s Mechanical Autoinjector Combination Product platform

• Proficiency in Fit to Platform Assessments, Product Technical Review, and Lifecycle management product strategies

• Identify product issues/opportunities for ‘in scope’ device platforms and drive solutions for cross product implementation (within CPO, Product delivery and Supply Chain organizations)

• Consider platform boundaries across operations, commercial, and regulatory labeling

• Support appropriate prioritizing of programs, including product lifecycle management and compliance related activities

• Direct management of professional engineering team responsible for technical assignments