Senior Scientist, Process Development - Analytics Lead

BioSpace; Thousand Oaks (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Comprehensive employee benefits

Flexible work models

Job summary

Amgen in Thousand Oaks, CA is seeking a Process Development Senior Scientist to lead analytical strategy for pivotal product development. You will guide method development, qualification, and technology transfer across a cross-functional team focused on biologics and therapies.

You will supervise analytical support, contribute to regulatory filings, and drive improvements in process characterization and product quality. Strong communication and leadership are essential.

Qualifications

• PhD required or equivalent in life sciences.
• Strong analytical chemistry and biochemistry background.
• Experience with regulatory filings is a plus.

Responsibilities

• Supervise and provide technical support for analytical teams.
• Lead analytical work for pivotal clinical process development programs.
• Define the analytical target profile (ATP) for methods to monitor product quality.
• Oversee method development, qualification, remediation, and transfer to Quality Control.
• Manage activities at contract manufacturing and testing sites.
• Author CMC sections in regulatory documents.

Skills

Analytical chemistry

Biochemistry

Team leadership

Cross-functional collaboration

Technical writing

Education

Doctorate degree in Life Sciences

Tools

HPLC

CE-SDS

cIEF

GMP/GLP understanding

Job description

Amgen in Thousand Oaks, CA is seeking a Process Development Senior Scientist to lead analytical strategy for pivotal product development. You will guide method development, qualification, and technology transfer across a cross-functional team focused on biologics and therapies.

You will supervise analytical support, contribute to regulatory filings, and drive improvements in process characterization and product quality. Strong communication and leadership are essential.