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 (Upstream/Downstream)
Live
What you will do
Let's do this. Let's change the world! In this vital role you will have the outstanding opportunity to tackle a variety of challenges and responsibilities around our groundbreaking Mammalian Cell Culture, Bacterial Fermentation and Purification facilities. To keep everything running efficiently, you will be involved in applying process, operational, scientific expertise, basic compliance knowledge, analytical & troubleshooting skills to support manufacturing operations. This role will support non-standard shift, which might include weekends and/or extended hours as per business needs.
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.
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.
Complete assessments for CAPA applicability requests from other plants/sites
Complete assessment for new or changes in BOM's (Bill of Materials)
Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining methodologies in that area.
Win
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 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.
Proficiency in GDP (Good Documentation Practices) on a regulated environment
Knowledge in systems: Trackwise, Spotfire, CDOCS, and process monitoring platforms
Strong Technical Writing/presentation abilities, and excellent written/verbal communication skills in English and Spanish
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.
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:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and 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
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.
