Sr Engineer

SR ENGINEER I, PROCESS DEVELOPMENT (DOWNSTREAM)

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.

Lets do this. Lets 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.

• 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

We are all different, yet we all use our unique contributions to serve patients. The inspiring professional we seek is a strong team-player with these qualifications.

• High school diploma / GED and 10 years of biologics process development or commercial-scale technical support experience OR
• Associates degree and 8 years of biologics process development or commercial-scale technical support experience OR
• Bachelors degree and 4 years of biologics process development or commercial-scale technical support experience OR
• Masters degree and 2 years of biologics process development or commercial-scale technical support experience OR
• Doctorate degree

• Masters degree 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)

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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…