Sr Engineer, Process Development

Amgen • Holly Springs, NC

2d

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. SENIOR ENGINEER, PROCESS DEVELOPMENT What you will do Let’s do this. Let’s change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group at Amgen’s FleX Batch Biologics Manufacturing Facility. 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. Responsibilities include: Apply fundamental scientific principles to Biopharmaceutical manufacturing processes (downstream purification) in the development of process improvements, facility adaptations, and new process operations. Provide technical leadership and on-the-floor support to assist in the troubleshooting of clinical and commercial drug substance manufacturing. Support the GMP manufacturing process tech transfer, evaluations, investigations, innovation and product life cycle management. Provide support for regulatory filing, inspection, and other CMC activities. Develop novel mammalian next generation technologies to increase yield, process robustness, and enable new unit operations. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The experienced scientific professional we seek is a leader with these qualifications.

Requirements

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

Nice To Haves

• 4+ years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role for drug substance manufacturing.
• Strong and in-depth expertise in biologics purification processes including chromatography, ultrafiltration and normal flow filtration operations
• Experience in process scale-up, technology transfer, facility fit, PPQ support, MFG troubleshooting, and complex investigation
• Able to apply engineering principles and statistical analysis, including Quality by Design (QbD) and design of experiments (DoE), in-order to solve processing issues and evaluate opportunities for process improvements
• Strong verbal and written communication skills, interact effectively with diverse internal and external stakeholders
• Demonstrated ability to work in moderate direction
• Be a self-starter with the ability to take on several projects at one time.

Responsibilities

• Apply fundamental scientific principles to Biopharmaceutical manufacturing processes (downstream purification) in the development of process improvements, facility adaptations, and new process operations.
• Provide technical leadership and on-the-floor support to assist in the troubleshooting of clinical and commercial drug substance manufacturing.
• Support the GMP manufacturing process tech transfer, evaluations, investigations, innovation and product life cycle management.
• Provide support for regulatory filing, inspection, and other CMC activities.
• Develop novel mammalian next generation technologies to increase yield, process robustness, and enable new unit operations.

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: Mid Level
• Number of Employees: 5,001-10,000 employees