Career Category

Job Description

Process Development Scientist

ARI

HOW MIGHT YOU DEFY IMAGINATION?

Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Live

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 through marketing application.

Amgen is seeking a Process Development Scientist to join the Commercial Drug Substance Technologies (DST) organization in West Greenwich, RI. Work in a coordinated group in which cell culture and purification scientists work together to advance Amgen’s commercial manufacturing capabilities through industry leading innovation. You will develop, characterize and support the commercialization of biologics drug substance manufacturing process to ensure Amgen’s promise of “every patient, every time”.

Responsibilities:

• Lead a team of scientists to apply first principles approaches and utilize problem-solving skills to rapidly meet development and characterization challenges to build robust processes with efficient experimentation

• Develop strong teams and support staff in their career development

• Work closely with Attribute Sciences, Drug Product Technologies and partners in the Operations network

• Lead cross-functional teams that deliver robust drug substance commercialization data packages (including authoring of CMC sections of regulatory documents, interaction with regulatory agencies, and support of technology transfers)

• Drive innovation and utilize out-of-the-box thinking to lead or support technology advancement efforts at Amgen

• 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

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The collaborative professional we seek is a dynamic thought leader with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master’s degree and 4 years of scientific or operations experience

OR

Bachelor’s degree and 6 years of scientific or operations

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 cell culture and/or purification process development

• Scientific understanding of current bioreactor and purification technologies, as well as the ability to explore and develop new approaches to further advance innovation

• Understanding of protein characteristics and critical attributes to direct cell culture and/or development and product/process control strategies

• Independently uncovering and resolving issues associated with cell culture, harvest and purification 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

• Demonstrated ability to deliver on complex and challenging objectives in defined timelines

• Demonstrated eminence in the scientific community through a sustained record of peer reviewed publications

• Demonstrated success working with diverse team members in a dynamic, cross-functional environment

• Familiarity with design of experiments and statistical analysis of data

• Knowledge of license application and the drug development process

• Exposure to cGMP manufacturing and CMC components of regulatory submissions 

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com