Senior Principal Scientist, Process Development & Analytics

BioSpace; Thousand Oaks (CA); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Group medical, dental, vision

Stock-based long-term incentives

Flexible work models

Job summary

Amgen is seeking a Process Development Senior Principal Scientist to lead analytical efforts for late-stage oligonucleotide programs. The role focuses on developing, transferring, and validating analytical methods, shaping control strategies, and guiding cross-functional teams from development through commercialization.

Lead and mentor analysts, collaborate with manufacturing, quality, and regulators, and contribute to regulatory submissions and PPQ activities.

Qualifications

• PhD/PharmD/MD with scientific experience or MS with years of experience in pharma.
• Experience in analytical method development for small molecules and oligonucleotides.
• Strong communication and documentation skills for regulatory filings.

Responsibilities

• Lead a team of analysts supporting process development and analytics.
• Develop, transfer, validate analytical methods for late-phase programs.
• Collaborate with drug substance/product teams to meet project goals.
• Define analytical control strategies and support regulatory submissions.
• Provide concise summaries to leadership and oversee external sites.

Skills

Analytical leadership

Analytical method development

Cross-functional collaboration

Technical writing

Strategic leadership

Education

PhD in Analytical Chemistry (or related)

Tools

Mass spectrometry (MS)

UV spectroscopy

NMR

FTIR

Job description

Amgen is seeking a Process Development Senior Principal Scientist to lead analytical efforts for late-stage oligonucleotide programs. The role focuses on developing, transferring, and validating analytical methods, shaping control strategies, and guiding cross-functional teams from development through commercialization.

Lead and mentor analysts, collaborate with manufacturing, quality, and regulators, and contribute to regulatory submissions and PPQ activities.