30 days old

Process Development Scientist

Amgen
Cambridge, MA 02138
  • Job Code
    133671513
Amgen

Job ID: R-115573
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 Department in Cambridge, MA. This group develops the drug product formulation and fill/finish process for late-stage biologics. The Scientist will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen's drug product development. Proficiency in lyophilization cycle development and frozen/freeze-dried solid-state characterization of large molecule biologics is a must and additional experience with alternate modalities is desirable.

Responsibilities include:

  • Plan, design, execute, and document laboratory studies related to drug product formulation, and process development in support of commercialization and life cycle management.
  • Lyophilization cycle development, heat transfer modeling, scale-up, and frozen/freeze-dried solid-state characterization for lyophilized biologic formulations, as well as, for alternative modalities (RNA, live modalities, etc.).
  • Actively utilize advanced IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis.
  • Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products during Commercialization, as well as, supporting commercial products in lifecycle management.
  • Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
  • Contribute to progress reports and presentations to ensure management awareness of 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 scientific professional we seek is a collaborative team-player 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 Pharmaceutics, Biotechnology, Biomedical engineering, Material Science or related field.
  • 2+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field.
  • Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale-down model development, characterization, and scale-up.
  • Knowledge of/hands-on experience with formulation development for lyophilized drug products.
  • Prior experience related to lyophilization cycle development, modeling, heat transfer characterization, scale-up, and tech transfer. Deep understanding of cycle development and optimization is a plus.
  • Proficiency in multiple solid-state characterization techniques (e.g. DSC, XRD, FDM, etc.) for the physical characterization of frozen and lyophilized drug product formulations.
  • 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.
  • Aseptic processing experience and familiarity with cGMPs.
  • Experience that includes elements of new product development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments.
  • Experience with coding/scripting for automated data analysis and modeling to enable better access and standardization across the function
  • Strong problem solving and effective multi-functional interpersonal skills.
  • 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

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: 2021-04-09 Expires: 2021-05-10

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Process Development Scientist

Amgen
Cambridge, MA 02138

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