Senior Scientist, Process Development & Analytics Lead

BioSpace; Thousand Oaks (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Amgen in Thousand Oaks, CA is seeking a Process Development Sr Scientist to provide analytical leadership within Attribute Sciences. You will guide late-stage analytics, define ATPs, and oversee method development, qualification, remediation, and transfer to QC, collaborating with Drug Substance and Drug Product teams.

The role emphasizes cross-functional leadership, GMP/GLP compliance, and strategic innovation to support robust manufacturing processes across biologics and other modalities.

Qualifications

• Doctorate degree in a life sciences field or equivalent.
• Masters/Bachelors with directly related life science experience. Minimum 2–4 years depending on degree.
• Extensive experience in Analytical Chemistry and biopharma settings is preferred.

Responsibilities

• Supervise and provide technical support for analytical teams in late-stage product development.
• Lead analytical work to support pivotal clinical process development programs.
• Define the analytical target profile (ATP) and oversee development, qualification, remediation, and transfer of analytical methods to QC.
• Manage activities at contract manufacturing and testing sites.
• Author technical reports and CMC sections in regulatory submissions.

Skills

Analytical Chemistry

Biochemistry

Cross-functional leadership

Regulatory knowledge

Problem solving

Education

Doctorate degree

Masters + 2 years life science

Bachelors + 4 years life science

Associates + 8 years life science

High school diploma / GED + 10 years life science

Tools

HPLC methods

CE methods

GMP/GLP transfer

Job description

Amgen in Thousand Oaks, CA is seeking a Process Development Sr Scientist to provide analytical leadership within Attribute Sciences. You will guide late-stage analytics, define ATPs, and oversee method development, qualification, remediation, and transfer to QC, collaborating with Drug Substance and Drug Product teams.

The role emphasizes cross-functional leadership, GMP/GLP compliance, and strategic innovation to support robust manufacturing processes across biologics and other modalities.