Process Development Senior Scientist – Pre-Pivotal Drug Product

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Process Development Senior Scientist – Pre-Pivotal Drug Product

What you will do

Let’s do this! Let’s change the world!

In this vital role Amgen is seeking a Process Development Senior Scientist for the Pre-Pivotal Drug Product Technologies group in Thousand Oaks, CA. This role supports early-stage drug product development across diverse modalities including monoclonal antibodies, bispecifics, fusion proteins, antibody-drug conjugates, and oligonucleotides. The role involves designing and developing liquid, frozen, and lyophilized formulations; evaluating critical quality attributes (CQAs) relating to shelf-life stability, and in-use stability; and establishing robust, scalable fill/finish and drug product processes.

The ideal candidate will integrate formulation, analytical, and process data to guide product design, apply cutting-edge technologies (including AI/ML), and collaborate cross-functionally to deliver high-quality, stable, and manufacturable drug products for clinical development.

Responsibilities will include:

• Plan and execute formulation and fill/finish process studies for early-stage programs.

• Develop and characterize formulations (liquid, lyophilized, frozen) and lab-scale sterile filling.

• Build process understanding across unit operations to support scalable drug product strategies.

• Evaluate in-use compatibility and drug product stability under clinical conditions.

• Investigate CQAs (e.g., aggregation, chemical modification, surface interactions, etc.) to inform formulation and process decisions.

• Leverage high-throughput tools for formulation screening and processability assessments.

• Identify and address gaps in technologies impacting protein stability and interactions.

• Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making.

• Ensure development approaches are phase-appropriate, from discovery through clinical manufacturing.

• Author technical documents, risk assessments, IND/CTA/BLA regulatory sections, and tech transfer packages.

• Support successful technology transfer to manufacturing (internal or external CMOs).

• Present findings to internal/external stakeholders and participate in cross-functional teams.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a Self-starter with these qualifications.

Basic Qualifications:

• Bachelor’s degree and 5 years of scientific experience OR

• Master’s degree and 3 years of scientific experience OR

• Doctorate degree PhD OR PharmD OR MD and relevant post-doc where applicable

Preferred Qualifications:

• PhD in Pharmaceutics, Biotechnology, Biochemistry, Physical Biochemistry, or related field with 2–4 years of postdoctoral or industry experience.

• Proven experience in formulation development, stability testing, and fill/finish operations for biologics.

• Strong foundation in analytical and biophysical techniques (e.g., UPLC/HPLC, SEC, IEX, RP-HPLC, CE-SDS) applied to drug product development.

• Familiarity with phase appropriate development, manufacturability, and risk-based decision-making.

• Experience applying AI/ML (e.g., LLMs, in silico tools) to streamline innovation, processes, and optimize performance.

• Skilled communicator with experience presenting technical and strategic content across functional teams.

• Demonstrated experience with contributing to regulatory