SR ENGINEER I, PROCESS DEVELOPMENT (DOWNSTREAM)

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.

• 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.

Basic Qualifications:

• 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

Preferred Qualifications:

• 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)

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.

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Salary Range