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Process Development Associate Scientist - Pivotal AS Rapid Analytics (Viet Phan)

Cambridge, MA 02138
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Job ID: R-115550
Location: Cambridge, MA, US


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 Associate Scientist - Pivotal AS Rapid Analytics


What you will do

Let's do this. Let's change the world. In this vital role you will work supporting method development and product characterization for clinical candidate molecules in the pivotal stage of development.

Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces, and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) monoclonal and bispecific antibodies, bispecific T-cell engagers ("BiTEs"), live oncolytic viruses, and synthetic medic

Role Responsibilities:

  • Hands-on development, qualification, remediation, and transfer of analytical methods to Quality Control. Author technical protocols, reports and Standard Operating Procedures (SOPs) for analytical methods. Serve as analytical subject matter expert to support investigations and studies carried out by other functional areas.
  • Testing and characterization of protein and synthetic products to support Drug Substance and Drug Product process development, and to support regulatory filings. Execute studies, interpret results, author technical reports
  • Perform forced degradation studies and use LC/MS to support product characterization, understanding of product stability, and evaluation of product comparability.
  • Closely collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications.
  • Answer analytical and product quality questions from health authorities.
  • Providing expertise and evaluation of Amgen's platform and analytical technologies, helping to drive innovation and efficiency within Process Development.


What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The scientist professional we seek is a self-starter with these qualifications.

Basic Qualifications

Master's degree and 2 years of scientific experience


Bachelor's degree and 4 years of scientific experience

Preferred Qualifications

  • B.S. in Biochemistry or related field
  • Good general biochemistry laboratory skills
  • Expertise in chromatography including HPLC, UPLC, and CE
  • Experience performing mass spectrometry
  • Strong desire to learn and interest in science
  • Demonstrated proficiency in method development and experience with method technology transfer
  • Understanding of phase-appropriate GMP compliance and documentation
  • Strong technical writing skills
  • Well-organized; ability to multitask, effectively plan and follow through on complex projects, and to work both independently and in team


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.


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.

Posted: 2021-03-30 Expires: 2021-04-30

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Process Development Associate Scientist - Pivotal AS Rapid Analytics (Viet Phan)

Cambridge, MA 02138

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