Process Development Associate

About the Role

This role contributes to Amgen’s Drug Substance Process Development for late-stage clinical and commercial biologics programs. It involves the development, characterization, and scale-up of upstream and downstream manufacturing processes supporting Ph II/III clinical trials to marketing application. This position is within an integrated organization where cell culture and purification scientists work together. The role provides an 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. The Associate will utilize established platform approaches and problem-solving skills to address day-to-day experimental challenges. The role also involves contributing to technology development through innovative thinking and developing expertise in both cell culture and purification. The Process Development Associate will join a diverse team and report to a Process Development Principal Scientist.

Key Responsibilities

• 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.

Requirements & Tech Stack

• Bachelor’s Degree
• Associate’s degree and 2 years of Scientific experience
• High school diploma/GED and 4 years of Scientific experience
• Demonstrated ability to identify and solve problems by applying scientific and engineering principles, preferably in a process development environment.
• Strong communication and interpersonal skills, and the ability to work flexibly in a dynamic and collaborative environment with diverse team members.
• Familiarity with design of experiments and statistical analysis of data.

Qualifications

• Bachelor's degree in Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences.
• Experience and demonstrated interest in laboratory work, particularly hands-on experience with mammalian cell culture and/or purification operations.
• Basic understanding of cell culture, protein chromatography, and filtration principles.