Manufacturing Associate - Bulk Drug Substance Manufacturing Services - Days

Amgen; Holly Springs (NC); Presencial; USD 71.000 - 96.000; Jornada completa

Descripción de la vacante

Amgen Inc. in North Carolina is seeking a Manufacturing Associate to join the Bulk Drug Substance Manufacturing Services team during the Days Live shift.

You will support the ANC2 facility expansion, handling weigh/dispense of materials, media and buffers, and equipment setup to enable startup and ramp-up of operations. The role partners with QA/QC, F&E, PPIC and Manufacturing to ensure readiness, execute procedures, document in EBRs, and maintain a clean, compliant workspace.

Formación

• High School/GED with 2 years of regulated manufacturing experience; or equivalent.
• Associate’s Degree with 6 months regulated environment experience; or Bachelor's degree.
• Demonstrated ability to follow cGMP procedures and SOPs.
• Experience in a regulated biotech/pharma environment.
• Basic familiarity with cGMP manufacturing.

Responsabilidades

• Adhere to cGMP procedures and SOPs in daily work.
• Set up, clean, and sanitize equipment in assigned area.
• Weigh and dispense materials for buffers and medias.
• Prepare buffers, media, and process samples.
• Record data in Electronic Batch Records (EBRs).
• Collaborate with QA/QC, F&E, PPIC, Mfg., etc.

Conocimientos

Teamwork

Communication

MS Office

cGMP knowledge

Educación

High School/GED

Associate’s Degree

Bachelor’s Degree

Herramientas

EBR/MES

Delta V

Electronic Quality Systems

Descripción del empleo

Career Category Manufacturing Job Description Join Amgen's Mission of Serving Patients 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.

Manufacturing Associate - Bulk Drug Substance Manufacturing Services - Days Live

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), 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. You will also 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, and startup execution. As the facility transitions to steady-state operations, the role will shift toward routine manufacturing execution, reliable delivery of materials and prepared solutions, equipment operation, cGMP documentation, and continuous improvement. With general direction, the Associate will support 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 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 in assigned area
• Run and monitor critical process tasks per assigned procedures
• Buffer and Media preparation and transfer
• Weigh and dispense of materials to be used in the preparation of Buffers and Medias
• 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 escalation 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

Win 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 BioWork Certificate 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 to demonstrate desire and drive to learn and grow their understanding of operations and processes

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 No relocation assistance will be provided for these positions

Salary Range 70,985.20USD -96,038.80 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.