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.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Associate Manufacturing - Bulk Drug Substance Downstream - Days
Live
What you will do
Let's do this! Let's change the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). The essential position, which supports our critical 24/7 manufacturing operations,?works?a 12-hour 2-2-3 schedule from 5:45am to 6:15pm.?Associates will be completing operations on the floor in our downstream?area?and?will?be?responsible for?the manufacturing of cGMP (Current Good Manufacturing Practices) drug substances.?
With general direction, the Associate will support all floor operations in accordance with cGMP practices. As Amgen relies upon the regular attendance of staff members to meet legitimate business needs, staff must be able to work assigned 12-hour?shift, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations.?
Responsibilities will include...
Compliance:
Completes work in accordance with establishedcGMPproceduresand policies(Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance
Assure proper gowning and aseptic techniques are always followed
Process/Equipment/Facilities:
Perform hands-ondownstream bio-tech operations(Column Chromatography, Tangential Flow Filtrationamong others)including set-up, cleaning, sanitization, monitoring of equipment and assigned area
Run and monitor critical process tasksperassigned procedures
Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs])
Complete washroom activities: cleaning equipment, small to large scale, used in production activities
Initiate and own manufacturing related process deviations
Identify and escalateissues and concerns regardingdaily routine functionsrelated to process and tasks; may engage with team on potential solutions
Perform documentationfor assigned functions (i.e., equipment logs, EBRs)
Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities
Maintain an organized, clean, and workable space
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications.
Basic Qualifications:
High School/GED + 2 years manufacturingand/or other regulated environmentexperience
Or
Associate's Degree+ 6 monthsmanufacturing and/or other regulatedenvironmentexperience
Or
Bachelor's Degree
Preferred Qualifications:
Completion of NCBioWorksCertification Program
Experience inaregulated industry such asbiotechnology or pharmaceutical
Basic understanding andprocessexperience in a cGMPmanufacturing facility
Excellent verbal and written communication
Proficient MicrosoftOffice skills, and knowledge of other electronic systems such as EBR/MES, Delta V,andElectronicQualitySystems
An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes
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.
