Specialist, Manufacturing

2 weeks ago

New Albany, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Specialist, Manufacturing

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.

  • 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.

  • Collaborate with key cross-functional teams including, but not limited to, Quality, Engineering, Supply Chain, and Business Operations to ensure timely and accurate delivery of final packaged products.

  • 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 technology transfer/NPI process to assess requirements for documentation, materials, training, and equipment modifications.

  • Participate in continuous improvement initiatives, such as lean manufacturing, six sigma, and kaizen.

  • 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.

Win

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

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

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.

Amgen offers a Total Rewards Plan comprising 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 including:

  • 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 and bi-annual company-wide shutdowns

  • Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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.

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.

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