Thousand Oaks, CA, US
Jun 21, 2019
Required Education
Bachelors Degree
Position Type
Full time
The Process Development Scientist is part of Cleaning Characterization group based in Amgen's Thousand Oaks, CA corporate headquarters, who are responsible for the development of cleaning process design supporting new product introduction in Amgen internal and external manufacturing network for both drug substance and drug product. The cleaning characterization group develops new processes including chemistries, temperature and contact time that support the implementation of cleaning validation studies within Amgen manufacturing sites. The group supports investigation of deviations/non conformances, writes technical cleaning evaluation reports, and supports plant inspections, including Prior Approval Inspections (PAIs).

Job Responsibilities
  • Design and perform planned experiments for developing large-scale processes
  • Help develop new methods, apparatus and procedures for bench-scale characterization work and scale-up
  • Write technical reports, assessments, and procedures
  • Use characterization data to develop key operating parameters (KOPs), testing requirements and acceptance criteria for new product launches
  • Work with Quality, Engineering and Process Development to implement Validation requirements at full scale
  • Help write technical papers for internal and external publication

Basic Qualifications

Doctorate degree
Master's degree and 4 years of Scientific experience
Bachelor's degree and 6 years of Scientific experience

Preferred Qualifications
  • Chemical Engineering Background with validation and laboratory studies experience.
  • Design and execution of bench-scale experiments
  • Analytical methods: Total Organic Carbon (TOC), protein assays, gel electrophoresis, spectroscopic methods
  • Characterization and validation of processes for biologicals
  • Good knowledge of scientific principles, methodologies and practices
  • Lab methods, including handling and dispensing chemicals, preparing buffers and operation of common lab equipment, such as pH and conductivity meters
  • Strong interpersonal skills
  • Good written and verbal communication 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.

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.