Process Development Scientist

Career Category Scientific Job  Description Join Amgen’s Mission of Serving Patients 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

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 Scientist What you will doLet’s do this. Let’s change the world. In this vital role you will join Amgen’s Pre-Pivotal Drug Product Technologies organization, the Synthetics Enabling Technologies (SET) group in Cambridge, MA, is seeking a highly motivated and team-oriented individual for the position of Process Development Scientist. SET is a key Drug Product Technology interface with partners in Process Development and Research & Discovery.

This individual will provide solid state characterization, with a strong focus on solid state NMR (ssNMR) spectroscopy, for drug substance and drug product process development for synthetics and biologics programs in support of SET’s key responsibilities which include:
• Utilize advanced solid-state characterization methods (e.g. ssNMR) to support drug substance and drug product process development for synthetics and biologics programs.
• Drive lead optimization and form selection to meet discovery research and process development requirements (Target Product Profile).
• Perform synthetics molecule assessment (develop ability assessment) and preclinical formulation support.
• Perform biopharmaceutical assessments utilizing predictive in silico and in vitro models to identify development strategies.
• Provide early clinical support for synthetics liquid dosage forms (e.g. drug-in-bottle, parenteral) and technical transfers to support clinical manufacturing (GMP).This individual will carry out solid-state analysis and physicochemical characterization to aid solid form and formulation development of drug substances and drug products.  The primary responsibilities will include developing, implementing, and applying advanced ssNMR techniques to characterize the structures and interactions of small and large drug molecules.

The role will leverage these techniques to investigate and resolve complex scientific questions in pharmaceutical materials science.

Responsibilities:
Explore and implement ssNMR techniques to enhance productivity, robustness and efficiency of small molecules and biologics development.

Take a proactive role in developing and applying innovative ssNMR approaches, demonstrating creativity in solving complex technical problems, for example understanding excipient-drug interactions and quantitative analysis of heterogeneous mixtures.

Provide solid state characterization support to biopharmaceutics assessment, form screening/selection, and drug substance and drug product process development for synthetics and biologics programs.

Interface with partners in Process Development and Research and…