Senior Scientist, Process Development & Analytical Chemistry

Amgen SA; Thousand Oaks (CA); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, dental, vision coverage

Discretionary annual bonus program

Stock-based long-term incentives

Flexible work models

Job summary

Amgen, based in Thousand Oaks, CA, is seeking a Process Development Sr Scientist to lead analytical efforts in an advanced Attribute Sciences group. You will guide method development, qualification, and technology transfer for robust manufacturing processes across biopharmaceutical modalities, supporting both late-stage and pivotal clinical programs.

You will supervise a skilled team, collaborate across Drug Substance and Drug Product, and author regulatory documentation while advancing

Qualifications

• Doctorate degree or equivalent advanced life sciences degree.
• Master’s degree with 2+ years of related life science experience.
• Bachelor’s degree with 4+ years of related life science experience.
• Associate’s degree with 8+ years of related life science experience.
• High school diploma with 10+ years of related life science experience.

Responsibilities

• Supervise and provide technical support for a team that provides analytical support for late stage product development.
• Act as an Attribute Sciences Team lead for a program in pivotal clinical process development, being responsible for all analytical work to support the program.
• Define the analytical target profile (ATP) for methods used to monitor product quality and oversee development, qualification, remediation, and transfer of analytical methods to Quality Control.
• Manage activities at contract manufacturing and testing sites.
• Author technical reports and CMC sections in regulatory documents and respond to health authority questions.
• Drive product characterization to support process comparability studies and regulatory filings.
• Provide expertise on Amgen’s platform and analytical technologies to drive innovation and efficiency in Process Development.
• Help define strategies to improve the effectiveness and efficiency of the Attribute Sciences department.

Education

Doctorate degree

Master’s degree and 2 years of directly related life science experience

Bachelor’s degree and 4 years of directly related life science experience

Associate’s degree and 8 years of directly related life science experience

High school diploma / GED and 10 years of directly related life science experience

Job description

Amgen, based in Thousand Oaks, CA, is seeking a Process Development Sr Scientist to lead analytical efforts in an advanced Attribute Sciences group. You will guide method development, qualification, and technology transfer for robust manufacturing processes across biopharmaceutical modalities, supporting both late-stage and pivotal clinical programs.

You will supervise a skilled team, collaborate across Drug Substance and Drug Product, and author regulatory documentation while advancing