Process Development Associate

Employer
Amgen
Location
Thousand Oaks, California
Posted
Sep 25, 2018
Ref
R-63724
Required Education
Bachelors Degree
Position Type
Full time

Amgen is seeking a Process Development Associate at its Thousand Oaks CA site to join the Pivotal Drug Substance Technologies organization. The Process Development Associate will be responsible for the support of Drug Substance Process Development for large molecule programs in late stage clinical and commercial development, including commercial process development and process characterization.


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 role 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 position provides the unique opportunity of being able to work on multiple modalities from antibodies and oncolytic viruses to bi-specifics.

The successful candidate will perform experiments at the bench scale, spanning the end- to end drug substance process, including both cell culture and purification operations. The Process Development Associate will apply established platform approaches and utilize problem-solving skills to rapidly solve day- to day experimental challenges. Additionally, the Incumbent will utilize out-of-the-box thinking to contribute to technology development. Finally, the Process Development Associate will demonstrate the desire to expand and develop skills in both cell culture and purification, thereby further contributing to the integrated group.

The 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.

Key Activities for the Process Development Associate include:

  • Creates improvements in yield, efficiency and reliability and/or changes in equipment, scale, and raw materials
  • Performs small-scale bioprocessing experiments encompassing both upstream (cell culture) and downstream (purification) operations
  • Cell culture responsibilities may include maintaining cultures in shake flasks, culture bags, and benchtop bioreactors
  • Conducts purification experiments include, but are not limited to, protein chromatography, filtrations, and UF/DF operations
  • Designs suitable experiments and analyzing results to draw meaningful conclusions
  • Communicates work through oral presentations and written documentation including technical reports and GMP documents to support regulatory filings
  • Provides scientific technical support for technology transfer of processes to manufacturing sites

Basic Qualifications:

Bachelor's degree
OR
Associate degree and 4 years of Process Development experience
OR
High school diploma / GED and 6 years of Process Development experience

Preferred Qualifications:

  • Bachelor's degree in Chemical Engineering, Biochemical Engineering, Life Sciences, or other relevant sciences
  • Demonstrated 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
  • Motivated self-starter with excellent interpersonal and organizational skills
  • Demonstrated success working with diverse team members in a dynamic, cross-functional environment
  • Familiarity with design of experiments and statistical analysis of data
  • Motivated self-starter with excellent interpersonal and organizational skills

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.