Senior Scientist, Process Development - Analytical Leader

Amgen SA; Thousand Oaks (CA); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Flexible work models where possible

Job summary

Amgen in Thousand Oaks, CA, is seeking a Process Development Sr Scientist to join the Attribute Sciences within the PD organization. You will provide strategic analytical leadership to teams developing manufacturing processes for biologics, including monoclonal antibodies and ADCs, and collaborate with Drug Substance/Product colleagues.

The role requires a PhD/MD/PharmD with strong expertise in analytical method development, regulatory filings, and cross-functional leadership.

Qualifications

• PhD/PharmD/MD and post-doc where applicable.
• Advanced analytical chemistry experience in biologics.
• Experience in regulatory filings and cross-functional teams.

Responsibilities

• Supervise and provide analytical support for late stage product development.
• Lead analytical work for pivotal clinical process development programs.
• Define ATP and oversee method development, qualification and transfer to QC.
• Manage activities at contract manufacturing and testing sites.
• Prepare reports and regulatory sections, answer questions from health authorities.
• Drive product characterization for comparability studies and filings.
• Provide expertise on Amgen’s platforms and analytical technologies.

Skills

Analytical Chemistry

Biochemistry

Mass spectrometry

HPLC

Regulatory strategy

Cross-functional leadership

Technical writing

Education

Doctorate (PhD/MD/PharmD)

Master’s degree + 3 years experience

Bachelor’s degree + 5 years experience

Tools

Mass spectrometry

HPLC/CE methods

GMP/GLP knowledge

Job description

Amgen in Thousand Oaks, CA, is seeking a Process Development Sr Scientist to join the Attribute Sciences within the PD organization. You will provide strategic analytical leadership to teams developing manufacturing processes for biologics, including monoclonal antibodies and ADCs, and collaborate with Drug Substance/Product colleagues.

The role requires a PhD/MD/PharmD with strong expertise in analytical method development, regulatory filings, and cross-functional leadership.