Senior Principal Scientist, Analytical Process Development

BioSpace; Thousand Oaks (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Stock-based incentives

Job summary

Amgen is seeking a Process Development Senior Principal Scientist to lead a team of analytical scientists, developing, transferring, validating, and implementing analytical methods for late-stage oligonucleotide programs through commercialization.

You will shape analytical strategies and collaborate across Process Development, Manufacturing, Quality, Regulatory, and external partners to enable successful PPQ, regulatory submissions, and launches.

Qualifications

• PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, or related field.
• Experience in pharmaceutical/biotech industry focused on process/product development and analytical method development for small molecules, peptides, and/or oligonucleotides.

Responsibilities

• Lead a team of analysts in supporting process development and analytical method development for late-phase programs.
• Collaborate with drug substance/product development, manufacturing, quality, and regulatory teams to meet project objectives.
• Define analytical control strategies and implement methods for development of late-phase programs.
• Prepare concise cross-functional leadership summaries for key decisions.
• Oversee activities at contract manufacturing and testing sites.
• Draft technical reports and CMC sections for regulatory submissions.

Skills

Analytical chemistry

Mass spectrometry

Problem solving

Communication

Team leadership

Education

PhD in Analytical Chemistry

PharmD or MD with scientific experience

MS in Chemistry

Tools

MS

NMR

FTIR

UV

Job description

Amgen is seeking a Process Development Senior Principal Scientist to lead a team of analytical scientists, developing, transferring, validating, and implementing analytical methods for late-stage oligonucleotide programs through commercialization.

You will shape analytical strategies and collaborate across Process Development, Manufacturing, Quality, Regulatory, and external partners to enable successful PPQ, regulatory submissions, and launches.