Experienced Full Stack Associate Manufacturing I - Downstream - Night Shift Manufacturing Professional – Biotechnology and Pharmaceutical Industry Expert

About Amgen and the Role

At Amgen, we're driven by a shared mission to serve patients living with serious illnesses. As a member of our team, you'll be part of a collaborative, innovative, and science-based culture that's dedicated to making a lasting impact on the lives of patients. We're proud to be a leader in the biotechnology industry, with a focus on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. Our award-winning culture is built on a foundation of teamwork, integrity, and a passion for challenges.

As an Associate Manufacturing I - Downstream - Night Shift, you'll be part of our newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility. This state-of-the-art facility combines the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. You'll work alongside a talented team of professionals who share your passion for innovation and your commitment to excellence.

About the Role

In this dynamic role, you'll be responsible for supporting all floor operations in our manufacturing services, upstream or downstream area, and will be completing operations on the floor in our manufacturing services. You'll work in a cGMP (Current Good Manufacturing Practices) environment, ensuring that all work is completed in accordance with established procedures and policies. Your responsibilities will include:

• Compliance: Completing 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

About You

We're looking for a team player with a passion for challenges and a commitment to excellence. The ideal candidate will have:

• Basic Qualifications:
• High School/GED + 2 years manufacturing and/or other regulated environment experience
• Associate's Degree + 6 months manufacturing and/or other regulated environment experience
• 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

About Our Culture and Benefits

At Amgen, we're committed to creating a workplace that's inclusive, diverse, and supportive. We believe that our employees are our greatest asset, and we're dedicated to providing a comprehensive benefits package that includes:

• 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

About Our Commitment to Diversity and Inclusion

Amgen is an Equal Opportunity employer and is committed to creating a workplace that's inclusive and diverse. We believe that our employees are our greatest asset, and we're dedicated to providing a workplace that's free from bias and harassment. We're committed to recruiting, developing, and retaining a diverse workforce that reflects the communities we serve.

About Our Commitment to Accessibility

Amgen is committed to ensuring 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. If you require accommodation, please contact us to request assistance.

How to Apply

Seize this opportunity to make a significant impact. Apply now and take the first step towards a rewarding new role. Click on the link below to submit your application.

About Amgen

Amgen is a biotechnology pioneer since 1980, and we're committed to unlocking the potential of biology for patients suffering from serious illnesses. We're dedicated to developing innovative human therapeutics that improve health outcomes and dramatically improve people's lives. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Salary Range

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $67,083.00 - $84,094.00. Actual salary will vary based on several factors, including but not limited to, relevant skills, experience, and qualifications.