Manufacturing Specialist-Operational Readiness

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. 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.

Manufacturing Specialist-Operational Readiness

What you will do

Let’s do this. Let’s change the world. This role will support the execution of manufacturing/quality systems through leading manufacturing process/procedures, risk assessments, continuous improvement initiatives, training, and new product introductions. They will apply process, operation, compliance, analytical, and troubleshooting skills along with scientific and technical expertise to support Amgen Ohio’s operations.

Responsibilities may include, but are not limited to;

• Primary point of contact to support operations and the organization through planning, designing, monitoring, and optimizing manufacturing processes.
• Serve as the Subject Matter Expert (SME) for documentation, specifically responsible for initiating, revising, and/or approving technical content and manufacturing procedures (SOPs, WIs, Risk Assessments, Protocols & Reports) to ensure all procedures reflect current operations, regulatory requirements, and quality standards.
• Collaborate with key cross-functional teams including, but not limited to, Quality, Engineering, Capital Project, Process Development, Supply Chain, and Business Operations to ensure timely and accurate delivery of projects and final packaged products.
• Assist with process/equipment design and the execution of the process validation and generation of process validation protocols and reports.
• Participate in technology transfer/NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• Assist in generating training materials and/or provide training on scientific and technical aspects of our packaging process.
• Support process monitoring quarterly reports, requiring detailed data collection, understanding of process monitoring parameters and control limits, and evaluating results against site KPIs.
• Participate in continuous improvement initiatives, such as lean manufacturing, six sigma, and kaizen.
• Create and lead through Quality Systems records such as deviations and CAPAs, providing review of manufacturing process, equipment and systems during root cause analysis (RCA) investigations and trend evaluations.
• Provide impact and risk assessments for Change Control Review Board (CCRB) records as the change control owner.
• Drive process or equipment modification projects which must be thoroughly assessed, prioritized, justified, and completed in an efficient manner.
• Manufacturing SME and point of contact to participate in regulatory inspections/audits.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 2 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Or

Bachelor’s degree and 4 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Or

Associate’s degree and 8 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Or

High school diploma / GED and 10 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Preferred Qualifications:

• Detailed technical understanding of bioprocessing and manufacturing packaging operations
• Experience with Lean principals (Kaizen, Six Sigma, Operational Excellence) and knowledge of problem-solving techniques
• Experience in leading cross-functional teams and managing projects.
• Experience with electronic Quality Management Systems
• Skilled in performance of GMP production operations
• Regulatory knowledge
• Project management skills
• Knowledge of data analysis and control charting

What you can expect from 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, including remote and hybrid work arrangements, where possible

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

careers.amgen.com

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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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.