Process Development Associate - Pivotal Drug Substance

Cambridge, MA, US
Mar 22, 2019
Required Education
Associate Degree
Position Type
Full time
Amgen is seeking a Process Development Associate - Pivotal Drug Substance to join the Pivotal Drug Substance Technologies organization at our Cambridge, MA facility. The Process Development Associate - Pivotal Drug Substance will report to the Process Development Senior Scientist.

This lab-based Process Development Associate will be responsible for support of the development, characterization, scale-up and support of upstream and downstream processes to enable commercial advancement of programs from Ph II/III clinical trials to marketing application. This position is in an integrated 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 Process Development Associate provides the unique opportunity of being able to work on multiple modalities from antibodies and oncolytic viruses to bispecifics and siRNAs.

Pivotal Drug Substance Technologies organization at Amgen develops, characterizes and supports the commercialization of the drug substance manufacturing processes for all late-stage programs across the Amgen portfolio.

Responsibilities of the Process Development Associate include:
  • Performs experiments at the bench scale, spanning the end- to end drug substance process, including both cell culture and purification operations
  • Applies established platform approaches and utilizes problem-solving skills to rapidly solve day- to day experimental challenges
  • Utilizes out-of-the-box thinking to contribute to technology development
  • Demonstrates the desire to expand and develop skills in both cell culture and purification, thereby further contributing to the integrated group

Basic Qualifications:

Bachelor's degree


Associate's degree and 4 years scientific experience


High school diploma and 6 years scientific experience

Preferred Qualifications:
  • Bachelor's degree in Chemical Engineering, Biochemical Engineering, Life Sciences, or other relevant sciences with a demonstrated record of excellence
  • Ability to identify, develop and implement solutions to practical problems through application of fundamental scientific and engineering principles, preferably in a process development environment
  • Basic understanding of protein chromatography, filtration and cell culture principles; Hands-on experience with mammalian cell culture, and/or purification operations is a plus
  • Motivated self-starter with excellent interpersonal and organizational skills
  • Ability to be successful working with diverse team members in a dynamic, cross-functional environment
  • Familiarity with design of experiments and statistical analysis of data

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.