Process Development Pivotal Drug Product Senior Associate - MA

Process Development Pivotal Drug Product Senior Associate

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please follow the next steps.

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Process Development Pivotal Drug Product Senior Associate

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 engineers and scientists responsible for the technical aspects of Amgen's drug product commercialization and lifecycle management. Based in Cambridge, Massachusetts, Amgen is seeking a Process Development Senior Associate for Pivotal Drug Product Technologies Group to support late stage Drug Product formulation and fill/finish process development for large molecule modalities (e.g. monoclonal antibodies, Bispecific Tcell engagers (BiTEs) and fusion proteins). Participate in planning, designing, implementing, and documenting studies related to drug product formulation and process development of various biologics (antibody, BiTE, other proteins)by applying basic science/engineering skills and prior knowledge Evaluate product quality and process performance through analytical testing (e.g. protein conc, pH, U/HPLC, rCE, particle analysis, moisture content) Apply advanced digital tools to automate data structuring, analyze large and diverse datasets and build intuitive visualizations. Operate and maintain automated lab equipment in support of formulation and process scale up study and material generation Author/review technical protocols and reports and perform data verification Participate in team meetings by sharing study designs, results and technical challenges

What we expect of you:

We are all different, yet we all use our unique contributions to serve patients. The biotech/pharma professional we seek is a collaborative team-player with these qualifications:

• Basic Qualifications: High school diploma / GED and 6 years of Scientific, Engineering or Operations experience; OR Associate's degree and 4 years of Scientific, Engineering or Operations experience; Or Bachelor's degree and 2 years of Scientific, Engineering or Operations experience; Or Master's degree
• Preferred Qualifications: Degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related subject area
• 2+ years of experience in pharmaceuticals/biotechnology that includes formulation development, scale up process development, and technology transfer
• Knowledge of Drug Product unit operations (i.e. ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and experience with relevant analytical techniques (i.e. SEC, CEX, HIAC, MFI)
• Ability to learn new techniques and instrumentation, perform multiple tasks simultaneously, keep accurate records, adhere to instructions, and follow company policies
• Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g.SQL), as well as data visualization tools (e.g. Tableau, Spotfire) is a plus
• Ability to learn and rapidly adapt to new requirements in a fast paced environment
• Critical thinking, problem solving and independent research skills
• Good organizational skills with strong attention to detail
• Excellent communication (oral and written)