Executive Director, Process Development

Career Category:
Process Development 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 lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Let’s do this. Let’s change the world. In this vital role, you are responsible for scientific and technical leadership of Drug Substance (DS) manufacturing processes and Attribute Sciences functions at Amgen’s Puerto Rico site.

Oversight responsibilities span commercialization through full scale process validation and life‑cycle management of processes and methods for Amgen’s mammalian and microbial DS manufacturing facilities in Puerto Rico.

This executive leader will work in close collaboration with Manufacturing, Engineering, Finance, Supply Chain and Quality functions to enable progressive improvements in commercial processes and analytical methods.

You will have direct strategic responsibility for leading a team of 80+ scientists/engineers to support a growing portfolio with increased volumes. This position reports to the Vice President of Drug Substance Manufacturing, Amgen Manufacturing Limited (AML) and has a dotted line reporting to Vice President of Drug Substance Technologies, Process Development.

• Drug substance technology and analytical method transfer to and from the site
• Process validation at scale across the two DS manufacturing plants
• Drug substance and Attribute science CMC authoring activities for products, in partnership with Attribute Sciences
• Process monitoring activities, including real‑time multivariate statistical process monitoring
• Life cycle improvements in commercial process, including improvements to increase yields and reduce cost of goods manufactured
• Ensure manufacturing operations are aligned with the registered process
• Provide oversight and support for technical investigations
• Safety and compliance of process development activities
• Developing strategy, setting goals and priorities, allocating resources, monitoring project progress, and managing the organization’s budget

We are all different, yet we all use our unique contributions to serve patients. The executive we seek is a leader with these qualifications.

• Doctorate degree and 6 years of Scientific, Process Development and/or Technical Service experience
• Master’s degree and 10 years of Scientific, Process Development and/or Technical Service experience
• Bachelor’s degree and 12 years of Scientific, Process Development and/or Technical Service experience
• 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

• PhD with 15+ years technical experience or a MS with 20+ years of technical experience in the field of biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline and 10+ years of managerial experience in a cGMP environment.
• Practical knowledge of the technologies related to analytical technologies, mammalian and microbial cell culture, protein purification, automation, validation and process engineering
• Strong technical communication skills, both written and verbal, to interact effectively with all stakeholders
• Experience in authoring marketing authorization…