Manufacturing Associate, Bulk Drug Substance Upstream - Days

BioSpace; Holly Springs (NC); On-site; USD 45,000 - 70,000; Full time

Benefits offered by this job

Flexible work model

Competitive benefits

Job summary

Amgen North Carolina (ANC) is seeking a Manufacturing Associate, Bulk Drug Substance Upstream - Days to join our production team. You will perform on-floor upstream operations for cgmp drug substance, with a 2-2-3,5 shift pattern and 12-hour days, ensuring safe, compliant manufacturing on the floor.

Working in a cross-functional team, you will support operations per cGMP, participate in process steps, and help maintain an organized, clean workspace.

Qualifications

• High School/GED + 2 years manufacturing/regulatory experience.
• Associates Degree + 6 months manufacturing/regulatory experience.
• Bachelor's Degree.
• NCBioWorks Certification Program completion.
• Experience in regulated biotech/pharma.
• Knowledge of cGMP manufacturing.
• Excellent verbal and written communication.
• Proficient MS Office; familiarity with EBR/MES, DeltaV, and Electronic Quality Systems.
• Willingness to learn and grow in operations.

Responsibilities

• Perform hands-on on-floor upstream manufacturing operations for CGMP drug substance.
• Support all floor operations per cGMP practices.
• Collaborate with QA/QC, Facilities & Engineering, PPIC, Manufacturing, Process Development, Regulatory, and others.
• Maintain an organized, clean, and safe workspace.

Job description

HOWMIGHT YOU DEFY IMAGINATION?

Youveworked 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,experienceand 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 over10 million patientsworldwide. 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 AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch 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

Letsdo this!Letschange the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). The scheduleisa rotating 2-2-3,5:45AM-6:15PM(12-hour shift).Associates will be completing operations on the floor inourupstreamareaandare responsible forthe manufacturing of cGMP (Current Good Manufacturing Practices) drugsubstance.

With general direction, the Associate will support all floor operationsin accordance withcGMPpractices.

Responsibilities will include...

Compliance

• Completes workin accordance withestablished 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,monitoringof equipment and assigned area
• Run andmonitorcritical process tasks per assigned procedures
• Perform in-process sampling,operateanalytical equipment, and complete process documentation (Electronic Batch Records [EBRs])
• Identifyand escalation issues and concernsregardingdaily 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 Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals weseekare 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 NCBioWorksCertification 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 todemonstratedesire and drive to learn and grow their understanding of operations and processes

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 Plancomprisinghealth 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 toparticipatein 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.