Senior Scientist, Process Development & Analytics Leader

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

Job summary

Amgen in Thousand Oaks, CA seeks a Process Development Sr Scientist to lead analytical science efforts in Attribute Sciences, guiding development of robust analytical methods and ensuring GMP/GLP compliance.

You will supervise analytical teams, drive ATP definitions, oversee method transfer, and collaborate with Drug Substance and Drug Product teams to support regulatory filings and product characterization.

Qualifications

• Doctorate or equivalent life science education and experience.
• Extensive experience with analytical method development and regulatory filings.
• Strong leadership and cross-functional collaboration skills.

Responsibilities

• Supervise analytical support for late-stage product development.
• Lead an Attribute Sciences program and oversee analytical work for the program.
• Define ATP for methods, oversee method development, qualification, remediation, and transfer to QC.
• Coordinate activities at contract manufacturing/testing sites.
• Prepare technical reports and CMC sections for regulatory filings.

Skills

Analytical Chemistry

Regulatory filings

Cross-functional leadership

Biochemistry

Education

Doctorate degree

Masters degree with 2 years related life science experience

Bachelors degree with 4 years related life science experience

Associates degree with 8 years related life science experience

High school diploma / GED with 10 years related life science experience

Tools

HPLC

CE-SDS

cIEF

Size-exclusion HPLC

Job description

Amgen in Thousand Oaks, CA seeks a Process Development Sr Scientist to lead analytical science efforts in Attribute Sciences, guiding development of robust analytical methods and ensuring GMP/GLP compliance.

You will supervise analytical teams, drive ATP definitions, oversee method transfer, and collaborate with Drug Substance and Drug Product teams to support regulatory filings and product characterization.