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. ENGINEER, PD PROCESS VALIDATION & BUSINESS STRATEGY

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 (PD DST) at Amgen’s FleX Batch Biologics Manufacturing Facility. This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes development, support, and execution of process validation. The role will be responsible for ensuring process validation activities are performed in a consistent and controlled manner to support manufacture of drug substances. In addition, the role will be responsible for driving PD business strategy activities and providing cross-functional tech transfer support.

• Lead the development of Process Validation/Process Performance Qualification strategy for New Products, ensuring alignment with regulatory guidelines and industry standards.
• Apply a fundamental understanding of Upstream (Cell Culture) and Downstream (Purification) bioprocessing to support process validation, technology transfer support, and plant start-up
• Lead the execution of validation projects and/or protocols and the collection of data to ensure completion of process validation activities.
• Provide cross-functional process monitoring support as needed
• Provide guidance for the generation, resolution and closure of deviations.
• Lead ANC PD business strategy activities to improve network practice, develop digital tools, and optimize the ANC PD business operations
• Ensure safety and compliance of process development activities
• Provide process validation floor process support as required
• Lead process validation support for regulatory filing, inspection, and other CMC activities

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.

Basic Qualifications:

• High school diploma / GED and 10 years of biologics process development, process engineering, or process validation experience OR
• Associate’s degree and 8 years of biologics process development, process engineering, or process validation experience OR
• Bachelor’s degree and 4 years of biologics process development, process engineering, or process validation experience OR
• Master’s degree and 2 years of biologics process development, process engineering, or process validation experience OR
• Doctorate degree

Preferred Qualifications:

• 5+ years of experience in a process validation or downstream (purification) role supporting biopharmaceutical manufacturing processes within regulated environments (i.e., cGMP)
• Strong and in-depth expertise of the operation of upstream and downstream manufacturing processes
• Validation experience with biopharmaceutical processes including PPQ, master plans, protocols, and reports
• Independently motivated with successful ability to multi-task and work in teams
• Demonstrated leadership skills and decision-making experience
• Experience in process scale-up, technology transfers, EBRs, deviation, CAPA, and change control processes.
• Excellent oral and verbal communication skills, interact effectively with diverse internal and external stakeholders

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.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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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.