Process Development Scientist
In this vital role you will contribute to Amgens 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 Amgens pipeline. Collaborate cross-functionally to ensure appropriate delivery of procedures and processes.
- Effectively functions as an Attribute Sciences representative on project teams. Responsibilities may include supervision and development of junior scientific staff members.
- Excellent teamwork and experience working in cross functional teams
- Excellent presentation skills and verbal and written communication skills
- 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 proteins 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 development molecule assessment, to improve method performance and to increase efficiency throughput the pre-pivotal stage.
- Investigation of method performance, reliability, and evaluation of impact of proposed changes.
- Deep understanding of product quality attributes and methodology to measure attributes, and to ensure proper control strategy.
- Support drug substance and drug product process development, and protein characterization
- 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
- Doctorate degree OR
- Masters degree and 4 years of directly related life science experience OR
- Bachelors degree and 6 years of directly related life science experience
- PhD in analytical chemistry, chemistry or biochemistry with 1+ years of experience
- Knowledge of analytical methods commonly used in the development of Biologics. Strong expertise in analytical method development, validation and troubleshooting for using HPLC/UPLC, CE and mass spectrometry etc.
- Strong interpersonal skills, along with outstanding verbal and written communication and problem solving skills are essential
- 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
- Proven record of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journals
- Responsible for laboratory activities (e.g. therapeutic protein analytical method development, protein process and formulation support and method transfers) for assigned projects, including but not limited to developing timelines and work plans.
- Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary environment.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.