Process Development Associate - Cambridge MA

Process Development Associate

In this vital role you will contribute towards Amgen's Drug Substance Process Development for late stage clinical and commercial biologics programs, including the development, characterization, and scale-up of upstream and downstream manufacturing processes supporting Ph II/III clinical trials to marketing application. This role is within an integrated organization in which cell culture and purification scientists work together to advance Amgen's rich and dynamic pipeline.

With Amgen's biology first approach, the position provides a unique opportunity to work on multiple modalities, from antibodies to oncolytic viruses to bi-specifics.

The Process Development Associate will help design and perform experiments at the bench scale that span the end-to-end Drug Substance process, from cell culture to purification operations. In this role, you will apply established platform approaches and utilize problem-solving skills to rapidly solve day-to-day experimental challenges. Additionally, the Process Development Associate will utilize out-of-the-box thinking to contribute to technology development and will demonstrate the desire to expand and develop expertise in both cell culture and purification, thereby further contributing to the integrated group.

The Process Development Associate will join a diverse team with varied levels of experience and report to a Process Development Principal Scientist.

Contribute within a project team on goals such as improving process yield and robustness, and scaling-up processes to manufacturing sites

Perform small-scale bioprocess experiments that encompass both upstream (cell culture) and downstream (purification) operations

Cell culture responsibilities may include maintaining cultures in shake flasks, culture bags, and benchtop bioreactors

Purification experiments include, but are not limited to, protein chromatography, filtration, and UF/DF operations

Automation programming for benchtop bioreactors, chromatography systems, and robotic liquid handling systems

Experimental design and data interpretation, leveraging in-house visualization and analytics tools

Communication of findings through oral presentations and written documentation (technical reports as well as GMP documents to support regulatory filings)

Provide scientific technical support for technology transfer of processes to manufacturing sites