Manufacturing Associate, Bulk Drug Substance Upstream - Days

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.

Manufacturing Associate, Bulk Drug Substance Upstream - 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 schedule   is   a rotating 2-2- 3,    5 :45A M-6:15P M   (12 - hour shift) .    Associates will be completing operations on the floor in   our   upstream   a rea   and   are responsible for   the manufacturing of cGMP (Current Good Manufacturing Practices) drug   substance .

With general direction, the Associate will support all floor operations   in accordance with   cGMP   practices.

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 operations 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])

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 professionals we   seek   are team players 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 Quality Systems

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

#AmgenNorthCarolina

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