Senior Process Development Scientist – Analytical Methods

Amgen; Thousand Oaks (CA); Hybrid; USD 126,000 - 171,000; Full time

Job summary

Amgen in Thousand Oaks, CA seeks a Process Development Senior Scientist to advance analytical development for late-phase programs. You will build control strategies, develop and validate methods, and transfer tech to CMOs as needed.

You’ll collaborate with drug substance and product teams and provide data for regulatory submissions to drive programs toward approval. The role emphasizes analytical chemistry proficiency, cross-functional leadership, and effective scientific communication within a

Qualifications

• Doctorate degree (PhD/PharmD/MD) or equivalent.
• Master’s degree with 3+ years of scientist experience.
• Bachelor’s degree with 5+ years of scientist experience.
• PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry or related discipline; strong MS experience.

Responsibilities

• Define analytical control strategies to support late-phase programs.
• Develop, validate, authorize and transfer analytical methods across modalities.
• Collaborate with drug substance/product teams to meet objectives and ensure data quality.
• Provide analytical data to support regulatory documents (CMC) and product development.
• May lead and mentor a small group of scientists.

Skills

Cross-functional leadership

Analytical chemistry knowledge

Technical writing

Regulatory understanding (CMC)

Education

Doctorate degree (PhD/PharmD/MD)

Master’s degree

Bachelor’s degree

Tools

Mass spectrometry (MS)

NMR spectroscopy

UV spectroscopy

FTIR spectroscopy

Job description

Amgen in Thousand Oaks, CA seeks a Process Development Senior Scientist to advance analytical development for late-phase programs. You will build control strategies, develop and validate methods, and transfer tech to CMOs as needed.

You’ll collaborate with drug substance and product teams and provide data for regulatory submissions to drive programs toward approval. The role emphasizes analytical chemistry proficiency, cross-functional leadership, and effective scientific communication within a