Senior Process Development Engineer Jobs in Raleigh, NC

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.

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 (Upstream and Harvest) 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.

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.

Basic Qualifications:

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

Preferred Qualifications:

• 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 upstream and harvest processes including cell expansion, cell culture, perfusion, centrifugation, 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.
• Prior experience with automation, Delta V, electronic batch record, commission/qualification with startup site is a plus.

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'll 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 of 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 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. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range