Process Development Senior Scientist

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Process Development Senior Scientist

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for development, characterization, scale-up and support of drug substance processes to enable commercial advancement of programs from Ph II/III clinical trials to marketing application. 

Work in a coordinated group in which cell culture and purification scientists work together to advance Amgen’s rich, exciting and dynamic pipeline. With Amgen’s biology first approach, the position provides the outstanding opportunity of being able to work on multiple modalities from antibodies and oncolytic viruses to bispecifics and siRNAs. 

The Pivotal Drug Substance Process Development organization at Amgen develops, characterizes and supports the commercialization of biologics drug substance manufacturing processes for all late-stage programs across the Amgen portfolio. 

• Apply established platform approaches and problem-solving skills to rapidly tackle drug substance challenges and build robust processes with efficient experimentation 
• Drive innovation and utilize out-of-the-box thinking to contribute to technology development 
• Expand and develop skills in cell culture and purification, thereby further contributing to the integrated group 
• Participate in drug substance teams and collaborate cross functionally with analytical and drug product representatives to deliver drug substance manufacturing processes in a phase appropriate manner. 
• Deliver process amenable to cGMP operation and carry out results of drug substance in a cGMP manufacturing environment 
• Author, or provide direction for the authorship of, technical report or CMC regulatory submissions which may require minimal additional editing 

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
OR
Master’s degree and 2 years of Life Sciences experience
OR
Bachelor’s degree and 4 years of Life Sciences  experience

Preferred Qualifications:

• Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, Bioengineering, Biomedical engineering, or Bioprocessing discipline or relevant experience in the pharmaceutical or related industry 
• Experience in bioreactor process development or cell line development 
• Scientific understanding of current bioreactor technologies, as well as the ability to explore and develop new approaches to further advance innovative bioreactor technologies 
• Understanding of protein characteristics and critical attributes so as to direct bioreactor development and product/process control strategies 
• Independently uncovering and resolving issues associated with cell culture and harvest and implementation of scientific projects 
• Strong technical communication skills, both written and verbal, to interact effectively and appropriately with all stakeholders and document learned information, improvements, and value generated 
• Motivated self-starter with excellent interpersonal and organizational skills 
• Leadership experience of progressively increased scope and a demonstrated ability to inspire and lead a group of scientists to deliver on complex and challenging objectives