Process Development Scientist
About the Job
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
What you will do
Let’s do this. Let’s change the world. In this vital role you will contribute to Amgen’s diverse process development portfolio of therapeutic modalities with a focus on understanding process and product properties of large molecule drug candidates and assessing the quality attributes of protein therapeutics being developed across multiple therapeutic areas in Amgen’s pipeline. Collaborate cross-functionally to drive the efficient transfer of technologies and to ensure appropriate delivery of procedures and processes. Responsible for analytical leadership of pre-pivotal programs, Scientific and technical expertise to advance the pre-pivotal portfolio Lead development and implementation of sophisticated analytical techniques.
- Routinely craft experiments that lead to a fundamental understanding of a therapeutic protein’s attributes and stability characteristics.
- Development and optimization of analytical methods (HPLC/UPLC, CE and Mass Spec) to support lead candidate selection for different modalities at Dev MA, to improve method performance and to increase efficiency and throughput at pre-pivotal stage.
- Investigates method performance, reliability, and evaluates impact of proposed changes.
- Deep understanding of product quality attributes and methodology to measure attributes, and to ensure proper control strategy.
- Optimally functions as an Attribute Sciences representative on project teams.
- Support drug substance and drug product process development and protein characterization, collects analytical data to be used for regulatory submissions, and participates in technology transfer activities.
- Authoring regulatory documents. Understanding of regulatory expectations for analytical methods, control and stability strategy and comparability.
- Work collaboratively with other scientists on multidisciplinary teams
- Keep current with field of expertise and evaluate emerging analytical technology
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The self-starter professional we seek is a scientist with these qualifications.
Master’s degree and 4 years of directly related life science experience
Bachelor’s degree and 6 years of directly related life science experience
- Ph.D. in biochemistry, chemistry, chemical engineering or other life science area plus 4 or more years of industrial experience.
- Strong lab skills to design and execute scientific experiments, interpretation of complex data and deliver results
- Strong expertise in analytical method development, validation and trouble-shooting for using HPLC/UPLC, CE and mass spectrometry etc.
- Strong proven experience in separation sciences, protein chemistry and/or mass spectrometry.
- Familiarity with commonly observed product quality attributes associated with therapeutic proteins (such as fragmentation, deamidation, oxidation, partial reduction etc.), and their characterization and quantification tools
- Prior experience authoring or contributing to regulatory filings.
- Work independently in advancing projects and studies within required deadlines.
- Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary environment
Some of the vast rewards of working here. 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.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor'
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.