Senior Biologics Process Development Scientist

Amgen Inc.; Thousand Oaks (CA); On-site; USD 126,000 - 171,000; Full time

Job summary

Amgen Inc. in Thousand Oaks, CA, is seeking a Process Development Senior Scientist to join the Pivotal Drug Product Technologies group.

You will drive formulation and process development for biologics, with emphasis on enzymes, mAbs, and peptides, integrating data across formulation, analytics, and manufacturing to deliver stable, manufacturable products. The role requires strong CQAs knowledge, proficiency with analytical techniques, and experience with AI-enabled tools.

Qualifications

• Doctorate degree PhD OR PharmD OR MD [and relevant post‑doc where applicable]
• Master’s degree and 3 years of Scientific experience
• Bachelor’s degree and 5 years of Scientific experience
• PhD in Pharmaceutics, Biotechnology, Chemical Engineering, Bioengineering, Biochemistry, or related field with 2–4 years of postdoc or industry experience
• Experience integrating formulation, stability, and analytical data for biologics including enzymes, mAbs and peptides
• Knowledge of protein stability, degradation pathways, quality attributes, and product/process comparability
• Experience with enzymes and formulation/co‑formulation development, fill‑finish process engineering, tech transfers
• Strong analytical and biophysical techniques (UPLC/HPLC, SEC, IEX, RP‑HPLC, HIC, CE‑SDS, subvisible particles)
• Programming and AI-enabled tools; data visualization (Tableau, Spotfire)
• Regulatory submissions experience (CTAs, BLAs) and cross‑functional collaboration
• Strong project management and ability to manage resources; independent research skills
• Ability to operate in fast-paced matrix environments

Responsibilities

• Participate in Drug Product Commercialization Teams for development and lifecycle support
• Design, plan, complete, and document formulation and process development studies
• Apply principles to develop and implement processes and next‑gen technologies
• Apply advanced statistical/data analytics to inform decisions
• Develop and characterize liquid biologics formulations, incl. co‑formulations
• Build process understanding across unit operations for scalable development
• Apply machine learning, AI, and data science to predictive modeling and workflows
• Author/review guidelines, protocols, reports, risk assessments, regulatory sections
• Support technology transfer and manufacturing through analyses and investigations
• Stay current with industry advances to meet future business needs
• Communicate progress to management and cross‑functional partners
• Lead cross‑functional initiatives to enhance drug product platforms

Skills

Analytical thinking

Programming

AI/ML familiarity

Communication

Education

PhD/PharmD/MD

Master’s with 3 years scientific experience

Bachelor’s with 5 years scientific experience

PhD in Pharmaceutics or related field

Tools

UPLC/HPLC

SEC

IEX

RP-HPLC

HIC

CE-SDS

Tableau/Spotfire

Job description

Amgen Inc. in Thousand Oaks, CA, is seeking a Process Development Senior Scientist to join the Pivotal Drug Product Technologies group.

You will drive formulation and process development for biologics, with emphasis on enzymes, mAbs, and peptides, integrating data across formulation, analytics, and manufacturing to deliver stable, manufacturable products. The role requires strong CQAs knowledge, proficiency with analytical techniques, and experience with AI-enabled tools.