Associate Manufacturing I - Downstream - Night Shift

Career Category Manufacturing Job Description Join Amgen?s Mission of Serving Patients? 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.??Associate Manufacturing (Night Shift) ? Downstream 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 initial schedule will be Monday-Friday, 8-hour days, and may include work from home. The schedule will transition to a 12-hour night shift as business needs dictate. Associates will be completing operations on the floor in our manufacturing services, upstream or downstream area and are responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance. With general direction, the Associate will support all floor operations in accordance with cGMP practices. 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 operations 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 Identify and escalate 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 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 Or Associate?s Degree + 6 months manufacturing and/or other regulated environment experience Or Bachelor?s Degree Preferred Qualifications: Completion of NC BioWorks Certification Program Single Use Systems (SUS) Experience Experience working in Drug Substance Downstream Manufacturing 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 What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we?ll support your journey every step of the way.? 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.? In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:? A 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? Flexible work models, including remote and hybrid 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?In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.??#AmgenNorthCarolina???Application deadline?Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.?As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.? Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.? 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. 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 67,083.00 USD - 84,094.00 USD Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

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