Senior AssociateManufacturing-Bulk Drug Substance Downstream-Nights

Senior AssociateManufacturing-Bulk Drug Substance Downstream-Nights Employer Amgen Location Holly Springs, North Carolina Start date May 19, 2026 View more categories View less categories Discipline Science/R D , Pharmacology Required Education High School or equivalent Position Type Full time Hotbed Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details

HOW MIGHT 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,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 over10 million patientsworldwide. 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 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. Senior AssociateManufacturing-Bulk Drug Substance Downstream-Nights Live What youwill do Letsdo this.

Letschange the world. In this dynamic role,you will beaSenior Associate inthemanufacturing organization atAmgenNorth Carolina (ANC).The essential position, which supports our critical 24/7 manufacturing operations,worksa 12-hour 2-2-3 schedule from 5:45pmto6:15am.

Associates will beexecutingoperations on the floorin our downstreamareaandwillberesponsible forthe manufacturing of cGMP (Current Good Manufacturing Practices) drug substances. With general direction, the Senior Associateis responsible forexecuting on-the-floor operations within manufacturingin accordance withcGMP practices.

As Amgen relies upon the regular attendance of staff members to meet legitimate business needs, staff must be able to work assigned 12-hourshift, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations. Responsibilitieswill 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 Initiate quality non-conformance (NC) reports Interact with regulatory agencies asneeded andguided Assure proper gowning and aseptic techniques arealways followed

Process/Equipment/Facilities:

Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation) Perform hands-ondownstream biotechoperations(Column Chromatography, Tangential Flow Filtration, Viral Filtration, Viral Inactivation, Column Packing among others)including set-up,operation,cleaning, sanitization,monitoringof equipment and assigned area Runandmonitorcritical process tasksperassigned procedures Perform in-process sampling,operateanalytical equipment, andcompleteprocess documentation(ElectronicBatchRecords[EBR]) Completewashroom activities:cleaning equipment, small to large scale, used in production activities Initiate and own manufacturing relatedprocessdeviations Identify, recommend, and implement innovative process improvements and optimizations related to daily routine functions Assistin the review ofdocumentation for assigned functions (i.e.,equipment logs,EBRs) Collaborateas part of across-functional team (i.e.,QA/QC,F&E (Facilities & Engineering), PPIC,Mfg.,PD (Process Development), Regulatory, etc.) in completing production activities Responsible forrecognizing andelevating problems during daily operations Participate in the implementation of programs and CAPAs (Corrective Action Preventive Action) with an eye toward continuous improvement Drive safety in all operations, andassistthe manager in escalating concerns as needed Maintain an organized, clean, and workable space

Administrative:

Draft and revise documents (SOPs, technical reports, and MPs) Interacts with managementas an advisorin planningandinescalatingpotential concerns withtheschedule and/or process Win What we expectofyou We are all different, yet we all use our unique contributions to serve patients. The hard-working professional weseekis ateam player with these qualifications.

Basic Qualifications:

HighSchoolDiploma/GED + 4yearsmanufacturing and/orotherregulatedenvironmentexperience Or AssociatesDegree+ 2 yearsmanufacturing and/orotherregulated environment experience Or BachelorsDegree+ 6 monthsmanufacturing and/orotherregulatedenvironmentexperience

Or Master'sDegree Preferred Qualifications:

Completion of NCBioWorksCertification Program Experience in biotechnology or pharmaceuticalplant start up Knowledge andprocessexperience within a cGMP manufacturingfacility or other highlyregulated environment Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation) Excellent verbal and written communication(technical) skills Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems Thrive 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 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 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 areprovidedreasonable 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. Company We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide. We live the mission. We win together. We thrive on continual challenge. Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission. At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health. Connect with us to explore how you can Win, Live, and Thrive at Amgen.

Company info Website http:

//careers.amgen.com/ Phone 805-447-1000 Location Corporate Headquarters One Amgen Center Drive Thousand Oaks California 91320-1799 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Instrument Technician Lebanon, Indiana Equipment Engineer 2 #4778, #4779 (Night Shift 10:00pm - 8:00am, Tue - Fri) Durham, NC