Biotherapeutics Process Development Lead

Biopharma Careers; Thousand Oaks (CA); On-site; USD 141,000 - 192,000; Full time

Job summary

Amgen is seeking a Process Development Principal Scientist to lead manufacturing process development and analytical strategy for biotherapeutics. You will guide cross-functional teams, design experiments to improve efficiency and quality, and Advance regulatory-compliant documentation.

The role requires deep protein biochemistry knowledge, leadership, and expertise in analytical methods such as HPLC/UPLC, CE, and mass spectrometry.

Qualifications

• - Doctorate or equivalent with relevant industry experience.
• - Strong leadership and collaborative skills.
• - Expertise in analytical methods for protein therapeutics.

Responsibilities

• Head research and development efforts related to manufacturing processes.
• Lead analytical assessment of Pre-pivotal biotherapeutic through development.
• Design experiments to understand protein attributes and stability.
• Apply analytical expertise to characterize therapeutics using CE, SEC, IEX, RP, HILIC, and MS.
• Evaluate method performance and regulatory documentation.
• Support drug substance/product development and technology transfer.

Skills

Analytical chemistry

Protein biochemistry

Leadership

Communication

Independent work

Education

PhD/PharmD/MD with 2+ years

MS with 5+ years

BS with 7+ years

Tools

HPLC/UPLC

CE

Mass spectrometry

Job description

Amgen is seeking a Process Development Principal Scientist to lead manufacturing process development and analytical strategy for biotherapeutics. You will guide cross-functional teams, design experiments to improve efficiency and quality, and Advance regulatory-compliant documentation.

The role requires deep protein biochemistry knowledge, leadership, and expertise in analytical methods such as HPLC/UPLC, CE, and mass spectrometry.