Specialist Manufacturing (AML6 Upstream/Downstream)

Career Category

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. 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.

Drug Substance Manufacturing Support – AML6 and AML7

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead the optimization of critical manufacturing processes, driving innovation and quality that directly impacts the lives of patients around the globe.

Specific responsibilities include but are not limited to:

• Own change controls for manufacturing process changes

• Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring process investigation reports, and presenting within regulatory inspections.

• Drive continuous improvement initiatives

• Support Risk Assessments exercises and Microbial assessment evaluations.

• Led commercial campaign readiness and effectively communicate and collaborate with cross function areas.

• Assist in the generation of training materials and assist in providing training on scientific or technical aspects of the process.

• Provide commercial support when needed and assist on the floor troubleshooting.

• Design, coordinate, and support execution of functional tests, water tests, and other runs to challenge process and operations during major changes, or campaign readiness. Generate technical protocols as needed.

• Assist and provide guidance during MBR (Master Batch Record) creation/revisions.

• Perform assessment to support process, automation, or equipment modification or implementation of special projects

• Initiate, revise, and approve standard manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.

• Assess process performance and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities as needed.

• Complete assessments for CAPA applicability requests from other plants/sites

• Complete assessment for new or changes in BOM's (Bill of Materials)

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Specialist Manufacturing professional we seek is an individual contributor leader with these qualifications.

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 2 years of Manufacturing Support experience

Or

Bachelor’s degree and 4 years of Manufacturing Support experience

Or

Associate’s degree and 8 years of Manufacturing Support experience

Or

High school diploma / GED and 10 years of Manufacturing Support experience

Preferred Qualifications:

• Educational background in Life Sciences and/or Engineering.
• In-depth experience of bio-processing unit operations
• Knowledge in Root Cause Analysis methodologies (Fishbone, Six Boxes, Fishbone, 5 Why’s, Kepner Tregoe)
• Familiar with Lean Manufacturing Practices
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
• Proven interpersonal and facilitation skills and ability to work in a collaborative team-based environment.
• Proficiency in GDP (Good Documentation Practices) on a regulated environment
• Knowledge in systems: Trackwise, Spotfire, CDOCS, MES, LIMS, and process monitoring platforms
• Strong Technical Writing/presentation abilities, and excellent written/verbal communication skills in English and Spanish

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.

In addition to the base salary, 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:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• 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 an annual site shutdown
• Flexible work models, including remote work arrangements, where possible

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

careers.amgen.com

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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