Associate Scientist

Thousand Oaks, CA, US
Jun 13, 2019
Required Education
Masters Degree/MBA
Position Type
Full time
Job Summary

Amgen is searching for an Associate Scientist to function as a member of the Commercial Drug Product Technologies team at Amgen. This role will be based in Thousand Oaks, CA and will primarily support the Process Engineering group. The Associate Scientist is responsible for assisting in lab scale studies supporting process development and tech transfer for drug product operations. This role will be a key contributor to drug product and process development, commercialization and life cycle management of Amgen's parenteral product portfolio.

This role provides development opportunities in the following areas:
  • Dynamic, matrixed organization and collaboration - the Associate Scientist interfaces with a broad array of partners on a routine basis, providing visibility to those other areas of the business and how these functions work together to meet organizational goals.
  • Operational efficiency and business skills application - this role provides an opportunity to apply core technical skills to Amgen's process development operations.
  • Process development - Provide technical input and support to the drug product tech transfer process by executing

In this role, the Associate Scientist will:
  • Work with a team of process scientists and/or engineers to design, execute, document, and generate primary data packages related to process development and technology transfer, while developing and applying their experience in aseptic processing, equipment, automation and unit operation characterization
  • Support continuous improvements in the drug product development process through technological innovation and application of first principles in process engineering
  • Support technology transfers of pipeline and commercial products as well as lifecycle management of products for a variety of parenteral modalities
  • Participate in global cross-functional teams, working effectively in a highly matrixed team environment to advance programs through the commercialization process

Basic Qualifications

Master's degree and 2 years of Scientific, Operations or Process Development experience
Bachelor's degree and 4 years of Scientific, Operations or Process Development experience

Preferred Qualifications
  • Experience in a role that working with cross functional groups to achieve results.
  • Highly proficient in presentation skills and the ability to draft technical documents.
  • Familiarity with aseptic processing, drug product manufacturing, cGMPs, statistical design, analysis of experiments, and process characterization
  • Fill/finish process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools
  • The ability to use engineering principles to leverage bench and pilot scale models for process performance characterization
  • 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

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.

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.