Amgen Process Development Scientist - Pivotal Drug Product in Cambridge, Massachusetts
Amgen is seeking a Process Development Scientist for our Pivotal Drug Product Technologies Group in Cambridge, Massachusetts. The team is responsible for late stage drug product formulation and fill/finish process development 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.
Lead the design and planning of laboratory studies related to formulation and fill/finish process development by applying basic science/engineering skills, first principle modeling, and prior knowledge
Execute and document laboratory studies with a high degree of technical rigor
Develop technical project plans to generate comprehensive data packages in support of commercial formulation/process development and process characterization
Author and review guideline documents, technical protocols, and reports
Author and review regulatory sections in support of Investigational New Drug (IND) and marketing application submissions
Manage multiple activities in parallel to drive project plans to completion, meeting project timelines and milestones
Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline and life-cycle management programs
Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software
Deliver progress reports and presentations to management on technical challenges, proposed solutions and results
Ability to travel domestically and internationally up to 10% of the time
Doctorate degree or Doctorate degree completed by May 2020
Master’s degree and 4 years of scientific experience
Bachelor’s degree and 6 years of scientific experience
Advanced degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related discipline
2+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field
Knowledge of/hands-on experience with formulation and commercial process development for liquid and lyophilized drug products
Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up
Understanding of physical/chemical stability of proteins and how process related stress impacts product quality, specifically, the impact of freezing and drying to short- and long-term stability
Strong problem solving and effective cross-functional communication skills
Experience with coding/scripting for automated data analysis and modeling
Experience with data visualization tools or packages, such as Tableau or Spotfire
Experience that includes elements of new product development, formulation development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
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.