Associate Scientist Thousand Oaks, CA
Thousand Oaks, CA - USA
Job Summary
Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Process Development Associate Scientist
What you will do
Lets do this. Lets change the 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 organizations 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
Required Experience:
IC
About Company
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