20 days old

Process Development Scientist

Amgen
Cambridge, MA 02138
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  • Job Code
    125985006
Amgen

Job ID: R-108017
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

Live

What you will do

Let's do this. Let's change the world. In this vital role you will join our Pivotal Drug Product Technologies Group in Cambridge, MA. This group is responsible for late stage drug product formulation and fill/finish process development for large molecule modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs) and fusion proteins). Working closely with a team of scientists and engineers, the successful candidate will apply scientific and engineering principles to advance the technical aspects of Amgen's drug product and process development. Additionally, the position would benefit from expertise in the application of data science and statistics to inform decisions throughout drug product development.

Responsibilities include:

  • Lead the design and planning of laboratory studies related to formulation and fill/finish process development by applying basic science/engineering skills, first principles modeling, and prior knowledge
  • Execute and detail laboratory studies with a high degree of technical rigor
  • Develop technical project plans to generate comprehensive data packages in support of commercial formulation/process development and process characterization
  • Author and review technical protocols and reports
  • Author and review regulatory sections in support of IND and marketing application submissions
  • Lead multiple activities in parallel to drive project plans to completion, meeting project timelines and milestones
  • Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline and lifecycle management programs
  • Perform data analysis using sophisticated statistical/analytical techniques with a proficiency in statistical analysis software
  • Contribute to progress reports and presentations to management on technical challenges, proposed solutions and results
  • Ability to travel domestically and internationally up to 10% of the time


Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The science professional we seek is a collaborative individual with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master's degree & 4 years of scientific experience

OR

Bachelor's degree & 6 years of scientific experience

Preferred Qualifications:

  • Advanced degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related discipline
  • 2+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field
  • Knowledge of/hands-on experience with formulation and commercial process development for liquid and lyophilized drug products
  • Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up
  • Understanding of physical/chemical stability of proteins and how process related stress impacts product quality, specifically, the impact of freezing and drying to short- and long-term stability
  • Strong problem solving and effective cross-functional communication skills
  • Experience with coding/scripting for automated data analysis and modeling
  • Experience with data visualization tools or packages, such as Tableau or Spotfire
  • Experience that includes elements of new product development, formulation development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
  • Demonstrated ability to learn and act on dynamic information at a rapid pace


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

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.



PI125985006
Posted: 2020-11-13 Expires: 2020-12-15

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Process Development Scientist

Amgen
Cambridge, MA 02138

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