Process Development Principal Scientist

Amgen is currently seeking a Process Development Principal Scientist for our Pre-Pivotal Attribute Sciences Group in Thousand Oaks, CA. This group supports analytical development for Amgens Early-Stage biologics. The Principal Scientist will be leading team of scientist and provide technical/project leadership to ensure success of early-stage clinical programs through the commercialization process.

• As a Principal Scientist within Pre-Pivotal attribute science, provide strategic, technical, and scientific leadership to the team.
• Lead the design and execution of phase-appropriate analytical strategy including analytical method development, method qualification, support process development and develop attribute control strategy.
• Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs
• Work in close partnership with Research to select clinical candidate during molecule assessment (MA) and lead pre-pivotal MA portfolio.
• Support Attribute science business process by authoring and reviewing guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions
• Drive technology development efforts to improve exciting platform methods and bring in new technologies to improve product development efforts.
• Authoring regulatory documents. Understanding of regulatory expectations for analytical methods, control and stability strategy and comparability.

Basic Qualifications

• Doctorate degree with 7-10+ years in Analytical chemistry, Biochemistry or equivalent.
• Relevant experience working as part of a multidisciplinary team in a biopharmaceutical setting would also be an advantage.

Preferred Qualifications

• Successful track record of managing and developing team of scientist.
• Strong background in bioanalytical research and development focusing on method development to study proteins and peptides using novel separation techniques.
• Proficient in other HPLC and CE methods such as reversed-phased HPLC, size-exclusion HPLC, ion-exchange HPLC, affinity HPLC, CE-SDS, and cIEF
• Demonstrate knowledge of regulatory requirements and guidelines and prior experience authoring or contributing to regulatory filings.
• Familiarity with commonly observed product quality attributes associated with therapeutic proteins (such as glycosylation, deamidation, oxidation, partial reduction etc.), and their characterization and quantification tools
• Strong problem solving and effective multi-functional interpersonal skills.

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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.

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