Associate Manufacturing Downstream - Nights (Multiple Positions)

BioSpace; Holly Springs (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health and welfare plans

Retirement and savings plan

Stock-based incentives

Job summary

Amgen North Carolina (ANC) is hiring for an Associate Manufacturing Downstream - Nights to support 24/7 operations in a new FleX Batch facility. The role involves on-floor downstream operations, 12‑hour shifts, and cGMP drug substance production in a highly automated environment.

Expect active collaboration with multiple functions and strict adherence to SOPs and safety guidelines. Qualifications include a high school diploma or equivalent, with additional college coursework or degree preferred.

Qualifications

• High School/GED + 2 years manufacturing and/or other regulated environment experience.
• Associates Degree + 6 months manufacturing and/or other regulated environment experience.
• Bachelor's Degree in a related field or equivalent experience.

Responsibilities

• Support 24/7 manufacturing operations on the downstream side of drug substance production.
• Perform cGMP tasks, operate in 12-hour shifts, and adhere to safety and compliance.
• Complete process documentation including EBRs and logs; maintain clean work area.
• Handle deviations and collaborate with QA/QC, F&E, PPIC, Mfg., and Regulatory as needed.

Skills

Verbal communication

Written communication

Team collaboration

Education

High School/GED

Associates Degree

Bachelor's Degree

Tools

EBR/MES

Delta V

Electronic Quality Systems

Job description

HOW MIGHT YOU DEFY IMAGINATION?
Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your bestworkalongside other innovative, driven professionals in this meaningful role.

HOW MIGHT YOU DEFY IMAGINATION?
Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your bestworkalongside 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 ManufacturingDownstream -Nights

(Multiple Positions)

Live

What Youwill Do

Lets do this! Lets 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 5:45pm to 6:15am. 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, Tangential 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 elevate 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

What We Expectofyou

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

• Associates Degree + 6 months manufacturing and/or other regulated environment experience

Or

• Bachelors Degree

Preferred Qualifications

• Completion of NCBioWorks 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

What You Can Expectofus

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

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 areprovidedreasonable 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.