Amgen Process Development Sr Associate in Thousand Oaks, California
Based in Thousand Oaks, CA, the role of Process Development Sr. Associate in Pivotal Drug Product Technologies will provide support for Amgen’s large molecule drug product formulation and fill/finish process development. The Sr. Associate will be responsible for performing formulation studies, evaluating the impact of process stresses on Drug Product attributes/stability, and process parameter definition for various fill finish unit operations. In addition, this role will focus on data analytics, statistical modeling, and data visualization.
Participate in the planning, design, execution, and documentation of studies related to drug product design, formulation development, and process development in support of commercialization and life cycle management of various modality biologics (antibody, BiTE, other proteins, viruses, RNA).
Perform analytical characterization supporting formulation attribute and stability assessments using chromatography and biophysical characterization tools (SE-HPLC, CE-SDS, DSC, NMR, HIAC).
Author and review technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.
Create visualizations to enable business application of data analysis.
Explore and evaluate new digital tools and techniques to improve the team’s developmental and operational capabilities
As needed, provide support to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.
Support standardization and optimization of departmental practices by contributing to guideline documents
Deliver progress reports and presentations to ensure management awareness and engagement of the current status, progress, and future program and functional needs.
Bachelor’s degree and 2 years of scientific experience
Associate degree and 6 years of scientific experience
High school diploma / GED and 8 years of scientific experience
Master’s degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related discipline
2+ years of experience in pharmaceuticals/biotechnology that includes elements of new product development, process characterization, formulation development, equipment design and implementation, technology transfers, statistical process control (SPC), and statistical design and analysis of experiments.
Experience with characterization of drug product formation and fill/finish unit operations (i.e. freeze/thaw, formulation, mixing, filtration, filling, and inspection)
Understanding of physical/chemical stability of proteins and how process related stress impacts molecule attributes and product quality
In addition to proteins, experience with alternate modalities (RNA or virus modalities) is a plus
Proficiency in at least one statistical software package (such as SIMCA or JMP)
Experience with data visualization tools or packages, such as Tableau or Spotfire
Experience with coding/scripting for automated data analysis and modeling to enable better access and standardization across the function
Aseptic processing experience and familiarity with cGMPs
Regulatory filings and compliance issues for sterile injectable products
Strong problem solving and effective cross-functional communication skills.
Proven ability to learn and act on dynamic information at a rapid pace.
If 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.