Process Development Scientist

Amgen Inc

Thousand Oaks, California, United States
Base: $111,940.75 - $151,449.25 usd annually; bonu...
**
Doctorate or master's degree with relevant experience
3+ years pharmaceutical process development experience
Deep understanding of product quality attributes and control strategies
** Amgen Inc is seeking a Process Development Scientist in Thousand Oaks, California, to lead analytical method lifecycle management and support commercial biologic products. The ideal candidate will have a strong background in analytical chemistry and experience in pharmaceutical/biotech process development. **

Job Summary

  • The role involves leading analytical method lifecycle management activities including remediation, improvements, and validation for marketed biologic products.
  • Candidates will contribute to global regulatory filings by authoring analytical CMC sections and ensuring the success of commercial approvals.
  • Amgen offers a comprehensive benefits package including retirement plans, health coverage, stock-based incentives, and flexible work arrangements.

Matching Summary

Match Score: 75

** Amgen Inc is seeking a Process Development Scientist in Thousand Oaks, California, to lead analytical method lifecycle management and support commercial biologic products. The ideal candidate will have a strong background in analytical chemistry and experience in pharmaceutical/biotech process development. **

Salary

Base: $111,940.75 - $151,449.25 USD annually; Bonus/Equity: Discretionary annual bonus program and stock-based long-term incentives available; Benefits: Comprehensive health, dental, vision, retirement plan, and flexible work models included

Skills & Requirements

Must-have

  • Doctorate or Master's degree with relevant experience
  • 3+ years pharmaceutical process development experience
  • Deep understanding of product quality attributes and control strategies
  • Commanding knowledge of chromatography, CE, bioassays, and immunoassays
  • Strong leadership skills in analytical project management
  • Solid understanding of GMP requirements and ICH guidance documents

Nice-to-have

  • Experience with QbD and PAT methodologies
  • Ability to provide diplomatic cross-functional leadership
  • Excellent technical writing and communication skills
  • Self-starter with strong decision-making capabilities
  • Experience managing commercial production method transfers

Key Requirements

  • Doctorate degree OR Master's with 2 years experience OR Bachelor's with 4 years experience
  • Advanced degree in Bioanalytical Chemistry, Analytical Chemistry, or related field preferred
  • 3+ years pharmaceutical/biotech experience in process and analytical method development
  • Sponsorship for this role is not guaranteed

Work Rights

Not specified

Tailored Resume

Cover Letter