20 days old

Senior Scientist-Pivotal Drug Product

Amgen
Cambridge, MA 02138
  • Job Code
    134286077
Amgen

Job ID: R-116644
Location: Cambridge, MA, US

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. 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. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

SENIOR 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 supports drug product commercial formulation development as well as formulation/fill/finish process development for Amgen's Late-Stage biologics. The Senior Scientist will provide technical and project leadership while integrating information generated by functionally diverse teams to ensure success through the commercialization process.

Responsibilities include:

  • Serving as a Drug Product Team Lead of matrixed team to develop strategy in support of commercialization and life cycle management of Amgen's pipeline.
  • Managing a team of engineers and scientists to advance program and functional objectives.
  • Lead planning, designing, executing, and documenting laboratory studies related to drug product design, formulation, and process development, tech transfer
  • Delivering progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.
  • Authoring and reviewing guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions.
  • Driving continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.
  • Serving as subject matter expert and help drive standard methodologies and technical advancements.
  • Expanding utilization of advanced IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis.
  • Working effectively in a highly matrixed team environment to influence and inspire change, efficiency, and foster positive relationships.
  • 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 biotech/biopharma scientist professional we seek is a collaborative team-player with these qualifications.

Basic Qualifications

  • Doctorate degree & 2 years of scientific experience or
  • Master's degree & 5 years of scientific experience or
  • Bachelor's degree & 7 years of scientific experience


Preferred Qualifications

  • Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related subject area
  • 8+ years of experience in pharmaceuticals/biotechnology.
  • 5+ years of experience that includes elements of formulation and fill/finish process development, process characterization, technical transfers to manufacturing sites, and statistical design and analysis of experiments, and regulatory authoring.
  • Technical leader with demonstrated results driving forward programs
  • Experience in drug product regulatory strategy, RTQs, and agency engagement.
  • Knowledge of, and hands-on experience with, bringing new biotech products to market, across various dosage forms and device delivery systems.
  • Experience participating and leading global multi-functional teams
  • Outstanding knowledge of formulation, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling, and the associated GMP/Device documentation and regulatory filings.
  • Strong problem solving and effective multi-functional interpersonal skills.
  • Willing and able to learn new technologies at a rapid pace


Thrive

What you can expect of us

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.
  • Vast opportunities to learn and move up and across our global organization
  • 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


Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. 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: 2021-04-17 Expires: 2021-05-18

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Senior Scientist-Pivotal Drug Product

Amgen
Cambridge, MA 02138

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