Senior Associate Manufacturing - Bulk Drug Substance Downstream - Days

About the role

Career Category Manufacturing Job Description Join Amgen’s Mission of Serving Patients   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.     Senior Associate Manufacturing - Bulk Drug Substance Downstream - Days Live   What you will do     Let’s do this! Let’s change the world! In this dynamic role, you will be an Senior Associate in the manufacturing organization at Amgen North Carolina (ANC) supporting the facility expansion program and facility startup. This essential role will be part of a team responsible for manufacturing  downstream purification operations including column packing, column chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill ,   while partnering across functions to ensure successful operational readiness, technology transfer, and 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 the startup, you will be expected to  work  a Monday – Friday schedule from 8am – 5 pm.   As the business moves from C&Q to manufacturing operations, this essential position   will   work on   a 12-hour 2-2-3 schedule from 5:45 am to   6:15pm   supporting our critical 24/7 manufacturing operations.    As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, th is role must be able to work assigned 12-hour   shift, including during inclement weather, some holidays and requested overtime in support of our operations.   During early phases, this role will focus on operational readiness, training, and startup execution. As the facility transitions to steady state operations, the role will shift toward routine manufacturing execution and continuous improvement.       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   Initiate Quality observations (Discrepancies, Deviations, Testing Results Analysis (TRA), etc.) as well as support or lead evaluations and investigations into quality observations   Interact with regulatory agencies as needed and guided   Assure proper gowning and aseptic techniques are always followed   Operational Readiness & Facility Startup   Support operational readiness activities for facility expansion and startup   Execute manufacturing readiness tasks including equipment preparation, procedure execution, and process walkthroughs   Participate in commissioning, qualification, and startup activities as trained and assigned   Provide operational feedback during startup activities to support safe, compliant, and efficient manufacturing   Support readiness planning through execution of training, procedures, workflows, and operational practices required for startup and ramp ‑ up   Process/Equipment/Facilities:    Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment of 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 [EBR])   Complete washroom activities: cleaning equipment, small to large scale, used in production activities   Identify, recommend, and implement innovat ive process improvements and optimizations related to daily routine functions   Assist in the review of documentation for assigned functions (i.e., equipment logs, EBRs, ESPs)   Collaborate cross-functional ly (i.e., QA/QC, F&E (Facilities & Engineering), PPIC (Production Planning and Inventory Control), Mfg., PD (Process Development), Regulatory, etc.) in completing production activities   Responsible for recognizing and elevating 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, and assist the 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 management as an advisor in planning and in escalating potential concerns with the schedule and/or process     Win   What we expect of you   We 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 experience OR   Associate’s Degree + 2 years manufacturing and/or other regulated environment experience OR   Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience OR   Master's Degree     Preferred Qualifications:       Completion of NC BioWorks Certification Program   Experience in biotechnology or pharmaceutical plant start up    Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment      U nderstanding 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 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     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 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.     . Salary Range 86,048.05USD -116,417.95 USD