Amgen Process Development Sr Associate in Cambridge, Massachusetts
Amgen is currently seeking a Process Development Senior Associate for our Pivotal Drug Product Technologies Group in Cambridge, MA. This group develops late stage drug product formulations and fill/finish processes for large molecule modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs), and fusion proteins). Working closely with a team of scientists and engineers, the successful candidate will apply scientific and engineering principles to advance the technical aspects of Amgen’s drug product and process development.
Participate in the planning, design, completion, and documentation of studies related to drug product design, formulation development, and process development in support of the commercialization of biologic therapeutics.
Author and review technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
Actively utilize IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis.
Build 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 improvements of departmental practices by adding to guideline documents.
Participate in global cross-functional teams working efficiently in a highly matrixed environment to progress product development.
Deliver progress reports and presentations to ensure management awareness and engagement of the current status, progress, and future program and functional needs.
Ability to travel domestically and internationally up to 10% of the time.
- Master’s degree or Master’s degree completed by June 2021
- Bachelor’s degree and 2 years of scientific experience
Master’s degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related field.
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 unit operation (i.e. filling, filtration, mixing, etc.) specific scale down models, characterization, and scale up.
Understanding of physical/chemical stability of proteins and how process related stress impacts molecule attributes and product quality.
Proficiency in at least one statistical software package (such as SIMCA or JMP).
Experience with coding/scripting for automated data analysis and modeling to enable better access and standardization across the function.
Strong problem solving and effective cross-functional interpersonal skills.
Established 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.