Process Development Associate - Microbiology

Career Category Operations 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 Associate - Microbiology What you will do Let’s do this. Let’s change the world. In this vital role you will work collaboratively with a team of scientists to execute studies supporting microbiological method development, optimization, and troubleshooting.  The role will primarily focus on laboratory execution while also contributing to study design, data analysis, as well as support scientists in drafting protocols/summary reports.  Activities also include the evaluation of new technologies/rapid microbiology methods (RMM). The successful candidate will perform studies independently and collaborate with scientists on study execution, support team on data analysis and drafting of protocols/summary reports. In addition, the PD Associate will interface with Amgen QC and other cross-functional partners and represent the Process Microbiology team in scientific and technical discussions. Execute laboratory studies supporting microbiological method development, optimization, troubleshooting, validation including (but not limited to): Endotoxin method/low endotoxin recovery (LER) studies Microbial Challenge/Hold time studies Bacterial Retention Testing/Sterile Filtration Studies Advancement of existing methods and implementation of alternative technologies, such as recombinant reagents for endotoxin testing and Monocyte Activation Test (MAT) for pyrogen testing Evaluation of RMMs Analyze and interpret experimental data, summarize study results, and assist with the preparation of protocols, technical assessments, reports Maintain knowledge of current compendial and regulatory requirements applicable to microbiological testing and microbial control, including USP, Ph. Eur., JP, and relevant regulatory guidance (Annex 1, CFRs, etc.) Collaborate with QC Microbiology, Process Development, Manufacturing, Quality and other functions to support the Amgen network Participate in and represent Process Microbiology in scientific and cross-functional meetings, including communicating study progress, study results, and technical findings Communicate effectively and efficiently with cross-functional team members, clients, and partner organizations Support day-to-day laboratory operations, including maintaining laboratory supplies and inventory, coordinating ordering of materials, and ensuring appropriate supplies are available to support study execution What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.

Requirement 1 Bachelor’s degree OR Associate’s degree and 4 years of Microbiology, related biological science experience OR High school diploma / GED and 6 years of Microbiology, related biological science experience Preferred