Process Development Sr Scientist

Responsibilities

• Provide strategic analytical leadership as an Attribute Sciences Team Lead for late-stage product development programs.
• Supervise and provide technical support for a team providing analytical support for pivotal clinical process development.
• Define Analytical Target Profiles (ATP) and oversee the development, qualification, and transfer of analytical methods to Quality Control.
• Manage activities at contract manufacturing and testing sites.
• Author technical reports and Chemistry, Manufacturing, and Controls (CMC) sections for regulatory documents.
• Drive product characterization to support process comparability studies, regulatory filings, and reference standard qualification.
• Evaluate Amgen’s platform and analytical technologies to drive innovation and efficiency within Process Development.

Requirements

• Doctorate degree OR Master's with 2 years of related experience OR Bachelor's with 4 years of related experience OR Associate's with 8 years of related experience OR High school diploma with 10 years of related experience.
• Extensive experience in analytical method development of biologics.
• Proficiency in HPLC and CE methods (e.g., reversed-phase, size-exclusion, ion-exchange, CE-SDS, and cIEF).
• Strong knowledge of regulatory requirements, CMC, and guidelines.
• Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

Preferred Qualifications

• Doctorate degree with 5-7+ years in Analytical Chemistry, Biochemistry, or an equivalent field.
• Experience working within multidisciplinary teams in a biopharmaceutical setting.
• Familiarity with product quality attributes such as glycosylation, deamidation, and oxidation.
• Experience with technical transfer for non-GMP and GMP production to external contract organizations.
• Experience with protein-based and live modality therapies (e.g., monoclonal antibodies, gene therapy).

Benefits

• Comprehensive health and welfare plans, including medical, dental, and vision coverage.
• Retirement and Savings Plan with generous company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans and flexible work models where possible.

About the Company

Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. Since 1980, we have pioneered advancements in oncology, inflammation, general medicine, and rare diseases, leveraging human genetics and biologics manufacturing expertise to deliver innovative medicines worldwide.