Director, Engineering - Clinical and Platform Secondary Packaging

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.

Director, Engineering - Clinical and Platform Secondary Packaging

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead all aspects of the packaging processes for clinical trial materials and platform packaging which are key to enabling commercialization of Amgen’s pipeline, ensuring that they meet regulatory requirements, protect product integrity, and facilitate effective clinical distribution. The Director is a key player in maintaining the highest standards of quality, efficiency, and compliance within the packaging operations.

• Leading a team of packaging professionals, providing guidance, training, and development opportunities to ensure optimal performance.

• Ensuring all packaging processes comply with regulatory standards such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant guidelines.

• Quality: Implementing rigorous quality measures to ensure the robustness, consistency, integrity and safety of packaging for clinical trials and commercial products.

• Process Optimization: Continuously improving procedures to enhance efficiency, reduce costs, and minimize waste.

• Materials Science and Engineering: Lead the evaluation and define fundamental requirements and evaluation for paper (natural fiber based), polymer, adhesives, clandestine security features and ink.

• Coordination: Collaborating with other departments such as Clinical Operations, External Supply Chain, and Regulatory Affairs to ensure seamless integration of packaging processes.

• Innovation: Staying abreast of new packaging technologies and trends and integrating innovative solutions to improve packaging operations.

• Technology management of materials and engineering standards which enable both modeling and rapid evaluation of new or alternate materials (Paper and Polymer/Adhesives) and modeling

• Oversight of pilot facilities to characterize and improve specifications and standards that enable rapid deployment to commercial facilities

• Collaboration with Human Factors to enhance our patient experience with a design for manufacturability approach

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 leader with these qualifications.

Basic Qualifications:

Doctorate Degree and 4 years of leadership in a regulated industry and/or engineering/materials science relevant experience

Or

Master's degree and 8 years of leadership in a regulated industry and/or engineering/materials science relevant experience

Or

Bachelor's degree and 10 years of leadership in a regulated industry and/or engineering/materials science relevant experience

In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• A degree in Mechanical Engineering, Materials Science, Chemical Engineering, Packaging Engineering, Pharmaceutical Sciences, or a related field

• Deep understanding of biopharmaceutical/pharmaceutical or food packaging design, materials sciences, and modeling

• Understands Biotechnology’s commercialization processes, manufacturing process/equipment

• 10+ years of business experience leading multi-functional multidisciplinary development organization in the healthcare industry