Process Development Senior Scientist

Career Category

Scientific

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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

What you will do

Let’s do this. Let’s change the world. In this vital role you will join Amgen’s Pivotal Drug Product Technologies group in Thousand Oaks, CA. The group supports drug product commercial formulation development as well as formulation/fill/finish process development for Amgen’s Late-Stage biologics portfolio.

The ideal candidate will bring hands-on experience in biologics drug product formulation and co-formulation, with experience across multiple modalities, including enzymes, monoclonal antibodies (mAbs), and peptides. The candidate will have a strong understanding of protein attributes, stability and process-related degradation pathways, and analytical strategies for characterizing critical quality attributes (CQAs). This role will integrate formulation, analytical, and process data to guide product design and development. The successful candidate will apply innovative technologies, including AI and machine learning where appropriate, and collaborate across functions to deliver high-quality, stable, and manufacturable drug products in a fast-paced environment.

• Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management
• Design, plan, complete, and document formulation and process development studies
• Apply scientific/engineering principles and techniques to develop, characterize and implement processes and next generation technologies and to solve technical challenges
• Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions
• Develop and characterize liquid formulations for biologics, with particular emphasis on enzyme drug product formulation or co-formulations
• Build process understanding across unit operations to support scalable drug product development
• Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making
• Author/review guideline documents, technical protocols and reports, risk assessments, and regulatory sections in support of IND and marketing application submissions
• Provide support to clinical and commercial technology transfer activities and manufacturing operations through process fit assessments, process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigations
• Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs
• Effectively and consistently communicate with management, cross-functional partners and relevant team members on progress towards achievements and forthcoming program needs
• Lead cross functional initiatives enhancing drug product platforms and contribute to process design improvement projects

What we expect of you

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

Basic Qualifications:

Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
OR
Master’s degree and 3 years of Scientificexperience
OR
Bachelor’s degree and 5 years of Scientific experience

Preferred Qualifications:

• 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 to advance biologics including enzyme, mAb and peptide candidates is highly desirable
• Demonstrated understanding of biologics drug product development considerations, including protein stability, degradation pathways, quality attributes, and product/process comparability
• Experience developing or characterizing enzymes, including assessment of activity, stability, and performance under relevant formulation or process conditions

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