Process Development Sr. Associate

Amgen is currently seeking a Process Development Sr. Associate 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 various biological modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs) and fusion proteins). The Sr. Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgens drug product commercialization and lifecycle management. Additionally, the position will have focus in the application of data science and statistics to inform decisions throughout drug product development

Responsibilities include:

• Plan, design, execute, and document laboratory studies related to formulation and fill/finish process development in support of product commercialization and life cycle management
• Apply basic science/engineering skills and first principle modeling to solve technical problems
• Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management.
• Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software.
• Provide support, as needed, 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.
• Author and review technical protocols, reports, and regulatory sections in support of INDa and marketing application submissions.
• Contribute to progress reports and presentations to management on technical challenges, proposed solutions and results

Basic Qualifications

Masters degree

OR

Bachelors degree & 2 years of scientific experience

We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek has the following qualifications:

• Masters degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related discipline.
• 2+ years industry experience in pharmaceuticals/biotechnology
• Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up
• Strong problem solving and effective cross-functional communication skills.
• 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.
• 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
• Ability to learn and act on dynamic information at a rapid pace.
• Strong organizational skills with attention to detail
• Excellent communication (oral and written)

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.