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
Doctorate degree and 2 years of scientific experience
Master's degree and 6 years of scientific experience
Bachelor's degree and 8 years of scientific experience
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 quantitation 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 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.