Sr Mgr Engineering

amgen; Holly Springs (NC); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision benefits

Life and disability insurance

Flexible spending accounts

Bonus program

Job summary

Amgen in the United States is seeking a Sr. Manager Engineering to provide scientific and technical leadership in the Process Development upstream group at Amgen’s Flex Batch Biologics Manufacturing Facility.

You will drive biologics technology transfer, process validation, and plant-startup support across the network, ensuring safety and regulatory compliance. You will lead cross-functional teams, manage complex investigations, and collaborate with drug substance teams to meet quality,

Qualifications

• Must have 8+ years in biologics process development or commercial-scale technical support.
• 2+ years direct people leadership required; manage teams or projects.

Responsibilities

• Lead a technical team focused on biologics technology transfer, process validation, and plant start-up support.
• Lead site activities for process monitoring, optimization, complex investigation, and product lifecycle management.
• Ensure safety and compliance of process development activities.
• Collaborate with other site-functions and network drug substance teams to deliver plant goals.
• Lead cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives.
• Ensure manufacturing operations align with the registered process.
• Support regulatory filings, inspections, and other CMC activities.
• Serve on the DST extended leadership team to advance capabilities.

Skills

Biologics process development

Leadership/people management

cGMP regulatory experience

Cross-functional collaboration

Regulatory filings/inspections

Education

Bachelor's degree in Biotech/related field

Master’s degree in Bioprocessing

PhD in Bioprocessing

Tools

Regulatory documentation tools

Job description

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 MGR ENGINEERING

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide scientific and technical leadership within the Process Development upstream 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.

• Lead a technical team focused on biologics technology transfer, process validation, and plant start-up support
• Lead site activities for process monitoring, optimization, complex investigation, and product life cycle management
• Ensure safety and compliance of process development activities
• Collaborate with other site-functions and network drug substance teams in delivering plant goals
• Lead cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives
• Assure manufacturing operations are aligned with the registered process
• Provide support for regulatory filing, inspection, and other CMC activities
• Serve as member of the Drug Substance Technology (DST) extended leadership team utilizing network thinking and innovative approaches to advance the drug substance organizational capabilities

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a leader with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of biologics process development or commercial-scale technical support experience OR
• Associate’s degree and 10 years of biologics process development or commercial-scale technical support experience OR
• Bachelor’s degree and 8 years of biologics process development or commercial-scale technical support experience OR
• Master’s degree and 6 years of biologics process development or commercial-scale technical support experience OR
• Doctorate degree and 2 years of biologics process development or commercial-scale technical support experience
  In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• 8+ years of experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP)
• 5+ years of management experience
• Strong and in-depth expertise in cell culture processes
• Experience in process scale-up, technology transfer, process validation, troubleshooting, and complex investigation
• Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders
• Experience developing staff to reach their full potential
• Knowledgeable in regulatory filings and inspections
• Familiarity in operational aspects of commercial biopharma manufacturing
• Familiarity in statistical analysis, analytical methods, and product quality attributes related to biological processing

What you can expect of us

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.

Application deadline

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

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.