Amgen Process Development Scientist in Thousand Oaks, California

Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The PA (Process Analytics) group's focus is exploring, developing, and implementing process analytical technology to enable real-time or near-real-time process and product monitoring, control strategy development, and release of drug substance and drug product of wide range of therapeutic modalities, including (but not limited to) monoclonal and bispecific antibodies, bispecific T-cell engagers ('BiTEs'), live oncolytic viruses, and synthetic medicines.

Key Responsibilities:

  • Develop and deploy PAT based methods to monitor Process Parameters and Product Quality Attributes for therapeutic proteins and synthetic molecules

  • Collect and analyze technical data, summarize the results in concise reports including conclusions and recommended actions

  • Champion the use of PAT data to assist decision-making for development and manufacturing processes

  • Explore, evaluate and introduce new PAT and sensor technologies to expand the in-process real time monitoring and control capabilities

  • Contribute to the development of PAT strategies with manufacturing and PD organizations to assure business requirements are fully met

Basic Qualifications

Doctorate degree

OR

Master's degree and 4 years of Scientific experience

OR

Bachelor's degree and 6 years of Scientific experience

Preferred Qualifications

  • PhD in Analytical Chemistry or Biochemistry with emphasis in chromatography, electrophoresis, automation, or spectrometry

  • Familiar with modern analytical techniques such as chromatography (HPLC, CE), MS, Spectroscopy (FTIR, Raman, NMR), and bioassay etc.

  • Experience with process analytical technologies (PAT) and data analysis (e.g. multivariate analysis and predictive modeling)

  • Knowledge of statistical processing of data, including related software like Excel, Spotfire, or JMP

  • Programming using Python, R, C++, and machine learning languages

  • Demonstrated ability to analyze and interpret analytical data

  • Strong technical aptitude for the identification, development, and implementation of novel analytical technologies

  • Familiarity with automation and implementing data management systems

  • Ability to compile and communicate complex datasets in a manner which facilitates informed decision-making

  • Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment

  • Strong abilities in trouble-shooting, problem-solving, and multi-tasking

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.