Associate Manufacturing – Downstream - Nights (Multiple Positions)

Career Category

Manufacturing

Job Description

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     –   Downstream -   Nights   (Multiple Positions)

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 5:45 p m to 6:15 a m. 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 established   cGMP   procedures   and 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-on   downstream bio-tech operations   (Column Chromatography, T angential Flow Filtration   among others )   including set-up, cleaning, sanitization, monitoring of equipment and assigned area

Run and monitor critical process tasks   per   assigned 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 escalate   issues and concerns regarding   daily routine functions   related to process and tasks ; may engage with team on potential solutions

Perform documentation   for 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 professional s   we seek   are   team player s   with these qualifications.

Basic Qualifications:

High School/GED + 2 years manufacturing   and/or other regulated environment   experience

Or

Associate’s Degree   + 6 months   manufacturing and/or other regulated   environment   experience

Or

Bachelor’s Degree

Preferred Qualifications:

Completion of NC   BioWorks   Certification Program

Experience in   a   regulated industry such as   biotechnology or pharmaceutical

Basic understanding and   process   experience in a cGMP   manufacturing facility

Excellent verbal and written communication

Proficient Microsoft   Office skills , and knowledge of other electronic systems such as EBR/MES, Delta V,   and   Electronic   Q uality   S ystems

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.

. Salary Range

70,985.20USD -96,038.80 USD