Process Development Scientist

Process Development Scientist
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What you will do

Let's do this. Let's change the world. In this vital role you will work 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. Additionally, the position would benefit from expertise in the application of data science and statistics to direct decisions throughout drug product development.

Amgen is currently seeking a Process Development Scientist for our Pivotal Drug Product Technologies Group in Cambridge, MA. This group 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).

• Own the design and planning of laboratory studies related to formulation and fill/finish process development by applying basic science/engineering skills, first principles modeling, and prior knowledge.
• Execute and detail 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 technical protocols and reports
• Author and review regulatory sections in support of 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 lifecycle management programs
• Perform data analysis using sophisticated statistical/analytical techniques with a proficiency in statistical analysis software
• Contribute to 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

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The science professional we seek is a collaborative driver of process with these qualifications.
Basic Qualifications

Doctorate degree OR

Master's degree & 4 years of scientific experience OR

Bachelor's degree & 6 years of scientific experience
Preferred Qualifications

• Advanced degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related subject area
• 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

Join Us

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.