Process Development Associate

Thousand Oaks, CA, US
Jul 17, 2019
Required Education
High School or equivalent
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.

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.

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.

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

Key Activities for the Process Development Associate include:
  • Typical project goals include improvements in yield, efficiency and reliability and/or changes in equipment, scale, and raw materials
  • Performing 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
  • Purification experiments include, but are not limited to, protein chromatography, filtrations, and UF/DF operations
  • Designing suitable experiments and analyzing results to draw meaningful conclusions
  • Communication of work through oral presentations and written documentation including technical reports and GMP documents to support regulatory filings
  • Providing scientific technical support for technology transfer of processes to manufacturing sites

Basic Qualifications

Bachelor's degree
Associate degree and 4 years of Process Development experience
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 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.