Sr Engineer I

Amgen • Holly Springs, NC

2d • $115,495 - $156,257

About The Position

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. SR ENGINEER I, PROCESS DEVELOPMENT (DOWNSTREAM) What you will do Let’s do this. Let’s change the world. In this vital role you will advance Amgen latest bioprocessing platform and technology, delivering high quality of medicine to patients around the world. The Sr. Engineer will be part of the Process Development-Drug Substance Technology at Amgen’s FleX Batch facility, focusing on technology transfer, process support, and optimization. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network.

Requirements

• High school diploma / GED and 10 years of biologics process development or commercial-scale technical support experience OR Associate’s degree and 8 years of biologics process development or commercial-scale technical support experience OR Bachelor’s degree and 4 years of biologics process development or commercial-scale technical support experience OR Master’s degree and 2 years of biologics process development or commercial-scale technical support experience OR Doctorate degree

Nice To Haves

• Master’s degree in in Engineering or Science discipline
• 5+ years of experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP)
• In-depth expertise in biologics process purification processes
• Experience in process scale-up, technology transfer, process validation, process optimization, troubleshooting, and complex investigation
• Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders
• Able to apply engineering principles and statistical analysis in resolving complex issues
• Knowledge in regulatory filings and inspections
• Knowledge in broad aspect of biologics processing, for example cell culture, analytical methods, or product quality attributes
• Familiarity in operational aspects of commercial biopharma manufacturing (e.g. process automation, equipment, single use)

Responsibilities

• Support technology transfer, process validation, and plant start-up
• Provide technical leadership in Downstream (Purification) Bioprocessing for process monitoring, optimization, yield improvement, complex investigation, and product life cycle management
• Partner with cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives
• Provide on-the-floor process support as required
• Ensure safety and compliance of process development activities
• Collaborate with other site-functions and network drug substance teams in delivering plant goals
• Support regulatory filing, inspection, and other CMC activities

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Senior