29 days old

Process Development Scientist - Pivotal Drug Substance

Amgen
Cambridge, MA 02138
  • Job Code
    133432192
Amgen

Job ID: R-116021
Location: Cambridge, MA, US

HOW MIGHT YOU DEFY IMAGINATION?

You've earned your degree. How will you use that achievement to reach your goals? 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.

Process Development Scientist - Pivotal Bioprocesses Sciences & Technologies

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 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


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 life sciences experience

OR

Bachelor's degree and 6 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 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

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.





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Posted: 2021-04-06 Expires: 2021-05-07

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Process Development Scientist - Pivotal Drug Substance

Amgen
Cambridge, MA 02138

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