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Job description
Senior Associate - Bulk Drug Substance Manufacturing Services - DaysHOW MIGHT YOU DEFY IMAGINATION?At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.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.What you will doLet's do this. Let's change the world! In this dynamic role, you will be a Senior Associate in the Manufacturing organization at Amgen North Carolina (ANC), supporting the ANC2 facility expansion and startup program. This essential role will be part of the Services team responsible for enabling manufacturing operations through weigh and dispense of raw materials, material receiving and handling, media, buffer, and solution preparation, and component preparation activities, including parts washing and autoclave operations.As a Senior Associate, you will provide technical and operational support to the Services area, help coordinate daily activities, support training and qualification of staff, and promote safe, compliant, and reliable execution. You will partner across functions to support successful operational readiness, technology transfer, facility startup, and the ramp-up of manufacturing operations within the new facility.This role may require work outside standard business hours, including non-standard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution. During this phase of startup, you will be expected to work a Monday through Friday schedule from 8:00 a.m. to 5:00 p.m. As the business transitions from C&Q to manufacturing operations, this essential position will move to a 12-hour, 2-2-3 schedule from 5:45 a.m. to 6:15 p.m., supporting critical 24/7 manufacturing operations.Because Amgen relies on the regular attendance of all staff members to meet legitimate business needs, individuals in this role must be able to work their assigned 12-hour shift, including during inclement weather, on some holidays, and during requested overtime in support of operations.During the early phases of the project, this role will focus on operational readiness, training, procedure development, equipment and process familiarization, startup execution, and coordination of Services activities. As the facility transitions to steady-state operations, the role will shift toward routine manufacturing execution, oversight of daily floor activities, troubleshooting, coaching and development of staff, cGMP documentation, and continuous improvement.With general direction, the Senior Associate will support and help lead Services floor operations in accordance with current Good Manufacturing Practices (cGMP), applicable procedures, safety requirements, and established production schedules.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 complianceInitiate deviation reportsInteract with regulatory agencies as needed and guidedAssure proper gowning and aseptic techniques are always followedProcess/Equipment/Facilities:Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment and assigned areaRun and monitor critical process tasks per assigned proceduresPerform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records (EBR))Complete washroom activities: cleaning equipment, small to large scale, used in production activitiesIdentify, recommend, and implement innovative process improvements and optimizations related to daily routine functionsAssist in the review of 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 activitiesResponsible for recognizing and elevating problems during daily operationsParticipate in the implementation of programs and CAPAs (Corrective Action Preventive Action) with an eye toward continuous improvementDrive safety in all operations, and assist the manager in escalating concerns as neededMaintain an organized, clean, and workable spaceAdministrative:Draft and revise documents (SOPs, technical reports, and MPs)Interacts with management as an advisor in planning and in escalating potential concerns with the schedule and/or processWinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The hard-working professional we seek is a team player with these qualifications.Basic Qualifications:High School Diploma/GED + 4 years manufacturing and/or other regulated environment experienceOr ?Associate's Degree + 2 years manufacturing and/or other regulated environment experienceOr ?Bachelor's Degree + 6 months manufacturing and/or other regulated environment experienceOrMaster's ? DegreePreferred Qualifications:Completion of NC BioWorks Certification ProgramExperience in biotechnology or pharmaceutical plant start upKnowledge and process experience within a cGMP manufacturing facility or other highly regulated environmentStrong understanding of solution prepar ation, equipment preparation, and inventory control operation sExcellent verbal and written communication (technical) skillsProficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality SystemsThriveWhat you can expect of usAs 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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleAmgen 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.
Worksite address
holly springs, NC, 27540, US
Who can apply
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