Associate Manufacturing – Downstream - Nights (Multiple Positions)

Amgen; Holly Springs (NC); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Flexible work models

Job summary

Amgen North Carolina is seeking an Associate in Downstream – Nights to support 24/7 manufacturing on a 12-hour 2-2-3 shift from 5:45pm to 6:15am. You will perform hands-on downstream biotech operations, uphold cGMP standards, and contribute to production of drug substances.

Ideal candidates will have related manufacturing experience and strong teamwork, communication, and software literacy, with flexibility for overtime and holidays as needed.

Qualifications

• High School/GED plus 2 years manufacturing or regulated environment experience.
• Associate’s Degree plus 6 months manufacturing or regulated environment experience.
• Bachelor’s Degree required or preferred depending on role.

Responsibilities

• Perform downstream bio-tech operations (e.g., Column Chromatography, Tangential Flow Filtration).
• Run and monitor critical process tasks per procedures.
• Complete process documentation (EBRs) and equipment logs.
• Maintain clean, organized work area and follow cGMP procedures.
• Collaborate with QA/QC, F&E, PPIC, Mfg., PD, Regulatory teams as needed.

Skills

Verbal communication

Written communication

Microsoft Office

Team player

Education

High School/GED

Associate's Degree

Bachelor's Degree

Tools

DeltaV

EBR/MES

Electronic Quality Systems

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)

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 5:45pm 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 escalation 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
• Associate’s Degree + 6 months manufacturing and/or other regulated environment experience
• 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

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.