Amgen Process Development Scientist - Pivotal Attribute Sciences 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 Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a 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.

Located in our Thousand Oaks, CA office, the PD Scientist will work supporting product characterization and method development for clinical candidate molecules in the pivotal stage of development.

Key responsibilities include:

  • Identifying and characterizing attributes of therapeutic proteins and synthetic molecules using advanced analytical techniques

  • Develop and apply novel sample preparation and analytical methods for analysis of therapeutic proteins and synthetic molecules with emphasis on chromatography and mass spectrometry (LC-MS/MS)

  • Assess a variety of quality attributes of therapeutic proteins with emphasis on chemical modifications including glycosylation, oxidation, deamidation, aspartate isomerization, hydroxylation and others

  • Work in an analytical group equipped with a variety of chromatographic systems and mass spectrometry platforms

  • Perform LC/MS analyses of therapeutic proteins using intact, reduced protein and peptide mapping, different chromatographic and electrophoretic techniques

  • Communicate (verbal and in written) scientific concepts and results

  • Follow protocols and procedures, maintain accurate records in an electronic lab notebook, and generate quality data for use in drug development and regulatory filings

  • Work collaboratively with other scientists on multidisciplinary teams

  • Work independently in advancing projects and studies within required deadlines.

  • Actively create or contribute to patent and publications

  • Keep current with field of expertise, participate and advance drug development, technologies and information services programs within Amgen

  • Demonstrate external scientific eminence

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 mass spectrometry

  • Documented theoretical knowledge and hand-on experience in peptide mapping of proteins, intact and reduced LC-MS analysis for identification and quantification of chemical modifications

  • Training and experience of operating Thermo Q-Exactive mass spectrometers and Agilent and Waters HPLCs and UHPLCs

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

  • Programming using R, VBasic, C++, machine learning languages

  • Demonstrated proficiency in solving complex problems, ability to work independently, proactively seek outside resources and collaborate, self-starter and team player with strong leadership and decision-making skills capable of providing mentorship to junior staff

  • Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects

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.