Process Development Senior Principal Scientist - ADC Drug Products

About the role

Amgen is hiring a Process Development Senior Principal Scientist to join its Pivotal Drug Product Technologies group in Thousand Oaks, CA. The group supports commercial formulation development and formulation/fill/finish process development for late-stage biologics. The Senior Principal Scientist provides technical and project leadership, integrating data from diverse teams to ensure success through commercialization.

Key responsibilities

• Lead planning, design, execution and documentation of laboratory studies on drug product design, formulation and process development, and tech transfer
• Deliver progress reports and presentations to management on program status and future needs
• Author and review guidelines, protocols, reports, product impact assessments, regulatory submissions and responses to regulatory questions
• Develop and characterize liquid and lyophilized formulations for biologics, with emphasis on ADC drug product formulation, handling and lab-scale sterile filling
• Lead internal and external technology transfer, including collaboration with CMOs/CDMOs, process fit assessments and troubleshooting during manufacturing campaigns
• Apply machine learning, AI and data science to predictive modeling, workflow acceleration and decision-making
• Serve as Drug Product Team Lead of a matrixed team supporting commercialization and life cycle management, and manage a team of engineers and scientists

Required profile

• Basic: PhD, PharmD or MD with 2 years of scientific experience, or Master's with 5 years, or Bachelor's with 7 years
• Preferred: advanced degree in engineering, pharmaceutics, biotechnology, material science or related field, 8+ years in pharma/biotech, 5+ years including formulation, fill/finish, technical transfers, statistical design and regulatory authoring
• Proven experience in formulation development, stability testing and fill/finish for biologics; direct ADC drug product formulation experience strongly preferred
• Understanding of ADC considerations (linker-payload stability, drug-to-antibody ratio, degradations, comparability) and experience integrating formulation, stability and analytical data
• Experience in drug product regulatory strategy, RTQs and agency engagement, and bringing biotech products to market
• Experience leading global multi-functional teams; domestic and international travel up to 10%

Required skills

• Analytical and biophysical techniques for ADCs and biologics (UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis)
• Programming (Python, R, MATLAB) and databases (SQL), data visualization (Tableau, Spotfire, D3.js)
• Statistical software (SAS, JMP or Minitab)
• Aseptic processing, manufacturing and GMP/Device documentation

What we offer

• Health, dental and vision coverage, life and disability insurance, retirement savings plan with company contributions
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives
• Time-off plans and flexible work models where possible