Process Development Senior Scientist - Drug Product Technologies

Responsibilities

• Design and develop liquid and lyophilized formulations for diverse biologic modalities, with a strong emphasis on antibody-drug conjugates (ADCs).
• Plan and execute formulation and fill/finish process studies for early-stage programs.
• Evaluate critical quality attributes (CQAs) such as aggregation, fragmentation, and drug-to-antibody ratio to inform design decisions.
• Build process understanding across unit operations to support scalable drug product development.
• Apply machine learning, AI, and data science to predictive modeling and workflow acceleration.
• Author technical documents, risk assessments, and regulatory sections for IND/CTA submissions.
• Support technology transfer activities and collaborate with CMOs/CDMOs.

Requirements

• PhD, PharmD, or MD (with relevant post-doc where applicable).
• OR Master’s degree with 3 years of scientific experience.
• OR Bachelor’s degree with 5 years of scientific experience.
• Proven experience in formulation development and biologics stability testing.
• Knowledge of fill/finish operations and lab-scale sterile filling.
• Proficiency with analytical techniques including UPLC/HPLC, SEC, and IEX.

Preferred Qualifications

• PhD in Pharmaceutics, Biotechnology, Biochemistry, or a related field.
• Direct experience in ADC drug product formulation and mechanistic understanding of linker-payload attributes.
• Experience integrating formulation, stability, and analytical data to advance candidates into clinical manufacturing.
• Experience applying AI/ML (e.g., LLMs, in silico tools) to optimize R&D performance.
• Strong communication skills with experience contributing to regulatory submissions (CTAs, BLAs).

Benefits

• Comprehensive health and welfare plans, including medical, dental, and vision coverage.
• Retirement and Savings Plan with generous company contributions.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.

About the Company

Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. Since 1980, we have pioneered advancements in oncology, inflammation, general medicine, and rare diseases, leveraging human genetics and biologics manufacturing expertise to deliver innovative medicines worldwide.