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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Process Development Scientist

Amgen is currently seeking a Process Development Scientist for our Pre-Pivotal Drug Product Technologies department in Thousand Oaks, CA. Amgen’s Drug Product Technologies (DPT) department within the Process Development (PD) organization plays a critical role in delivering a stable formulated product for first-in-human clinical trials. DPT provides an opportunity to collaborate with various Amgen departments delivering an expanded view for product development from clinical to commercial.

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will contribute to our diverse early-stage portfolio projects that support different therapeutic modalities (bispecific/multispecific, fusion proteins, mAbs, 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 methods, subvisible particle analysis, viscosity characterization, mass spectrometry, capillary electrophoresis.
• Active participation and representation of drug product process development group in cross-functional project teams across organization
• Continuous adherence to compliance and legal requirements 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

Additional responsibilities will include detailing and retrieving scientific results in HLEE notebooks and computer files for regulatory filings, participating in group and project meetings, and speaking publicly at departmental seminars. Deliver progress reports, presentations, expectations include both internal and external presentation of scientific data with an eventual external publication/patent track record. Participation in global cross-functional teams working optimally in a highly matrixed team environment to improve our understanding of therapeutic lead behavior. The candidate is expected to work positively and collaboratively to influence and encourage colleagues from discovery and development organizations

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

Doctorate degree OR Master’s degree and 4 years of scientific experience OR Bachelor’s degree and 6 years of scientific experience

Preferred Qualifications:

• PhD in Pharmaceutics, Biotechnology, Biochemistry, Physical Biochemistry, or related field with a minimum of 2+ years of post-doctoral or 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 understanding of predictive methods, protein stability and solubility
• Preferred experience in mass spectrometry (peptide mapping), physiological relevant assay characterization (for subcutaneous drug delivery)
• Preferred understanding of drug delivery and devices related to product development
• Proficiency in a statistical software (such as JMP), experience with data visualization tools or packages (Tableau or Spotfire)
• Strong independent problem-solving skills
• Ability to learn and act on dynamic information at a rapid pace, hard-working and collaborative attitude
• Excellent oral and written communication skills for timely documentation, presentation, and discussion of scientific results for a fast pace and cross functional environment.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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