Process Development Scientist Full-time

Process Development Scientist

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.

What you will do and what we expect of you

Let's do this. Let's change the world. In this vital role you will:

Deliver processes amenable to current Good Manufacturing Practices (cGMP) operation and carry out results of drug substance in a CGMP manufacturing environment; Drive innovation and utilize innovative 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; and Author, or provide direction for the authorship of, technical report or Chemistry, Manufacturing and Control (CMC) regulatory submissions, which may require minimal additional editing. May telecommute.

Requirements

Master's degree in Biotechnology, Bioengineering, Biochemistry, or related field and 3 years of experience involving the following:

Purification process development; Current bioreactor and purification technologies; UNICORN software with AKTA chromatography and tangential flow filtration systems; Protein characteristics and critical attributes such as process impurities like host cell proteins or DNA to direct process development, and product and process control strategies; Uncovering and resolving issues associated with cell culture, harvest and purification, and implementation of scientific projects; Designing experiments and statistical analysis of data; Good Manufacturing Practices (cGMP) and Chemistry Manufacturing and Control (CMC) components of regulatory submissions.