Associate Scientist

Career Category Operations 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.

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

• In this vital role you will contribute to our diverse early‑stage portfolio projects that support different therapeutic modalities (bispecific/multispecific, fusion proteins, mAbs, ADCs and oligonucleotides).
• The candidate is expected to have hands‑on experience in formulation development and stability characterization of large molecule drug candidates to assess their critical quality attributes supporting diverse therapeutic areas.
• The candidate will be responsible for drug product formulation and process development by providing scientific and technical expertise to advance the pre‑pivotal portfolio.
• Routinely plan, design, complete, and document stability studies related to FIH formulation development and fill/finish process development, in support of product commercialization.
• Responsible for design and execution of in‑use compatibility studies for clinical to mimic clinical dose preparation and administration.
• Conduct stability studies, to support liquid and lyophilized formulations. This will require knowledge of ultrafiltration‑diafiltration and other buffer exchange processes.
• Complete development of multi‑modality protein drug formulations and analytical characterization of proteins via HPLC/UPLC/2‑D HPLC methods, subvisible particle analysis, viscosity characterization, mass spectrometry, capillary electrophoresis, biophysical analysis.
• Active participation and representation of drug product process development group in cross‑functional project teams across organization.
• Continuous adherence to compliance and quality and compliance while meeting organization’s goals and priorities.
• Author/review guideline documents, technical protocols, technical transfer documentation, reports, product impact assessments, and regulatory sections in support of IND submissions.
• Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs.
• Meticulous data collection, documentation using electronic data capture systems.
• Ability to work in a matrixed team and present data cross functionally.

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

• Master’s degree OR Bachelor’s degree and 2 years of Scientific experience
• Associate’s degree and 4 years of Scientific experience
• High school diploma / GED and 6 years of Scientific experience

• Master’s degree in Pharmaceutics, Biotechnology, Biochemistry, Physical Biochemistry, Biophysics, or related field with a minimum of 3+ years of industrial experience in pharmaceutical/biotechnology or related field
• Understanding of physical/chemical stability of proteins and how process related stress impacts product quality
• Experience in antibody characterization, stability, and experience in development of parenteral control release delivery systems
• Sophisticated…