Associate Manufacturing - Days (A Shift)

Amgen • West Greenwich, RI

5d • Onsite

About The Position

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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. Associate Manufacturing - Days (A Shift) What you will do Let’s do this. Let’s change the world. In this vital role you will In this role, you will perform operations in Manufacturing (AR30), specifically in downstream operations, at Amgen's innovative Rhode Island facility. You will perform and monitor critical processes associated with protein purification while following Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs) and batch records. Additional Responsibilities: Perform in-process sampling of drug substance applying analytical equipment. Perform hands-on operations that include inspecting and installing single use components, chromatography operations, UF/DF operations, sample analysis, drug substance fill operations and breaking down vessels. Perform technical writing to draft and revise documents such as Manufacturing Procedures, Deviations, Safety Reporting, and Equipment logs. Conduct basic troubleshooting and assist in the review of documentation for assigned functions. Opportunities to participate in cross-functional teams to expand technical background in the bio-technologies industry. Identify, recommend and implement improvements related to CAPAs or Continuous Improvement initiatives. Maintaining an inspection ready work space. Organizing and maintaining material inventory in the manufacturing space. Collaborating with multiple computer systems (Delta V/EBRs) simultaneously to complete operations or troubleshoot issues on the floor. This role is expected to work a 12-hour shift on a rotating schedule. The shift pattern will be 7AM-7PM, with a two-week rotation covering 7 days per rotation. The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off. In addition any Sundays worked receive Premium pay. The schedule during the initial on-boarding phase for this role (2-6 weeks) will be administrative (Monday through Friday, approximately 8am to 5pm). What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is an excellent teammate with these qualifications.

Requirements

• High school/GED + 2 years of manufacturing or operations work experience
• Associate’s + 6 months of manufacturing or operations work experience
• Bachelor’s Degree in a related field

Nice To Haves

• Bachelor’s degree in Science or Engineering
• Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc.
• Knowledge of Single-use-Systems
• CFR and Regulatory knowledge
• Mechanical ability/expertise
• Basic statistical mathematical skills
• Ability to interpret and apply GMP knowledge
• Understanding of analytical methods for manufacturing area
• Demonstrated technical writing capability
• Able to demonstrate project management skills and presentation skills
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Basic troubleshooting skills on production equipment
• Experience with Delta V
• Experience with lab equipment/testing

Responsibilities

• Perform operations in Manufacturing (AR30), specifically in downstream operations, at Amgen's innovative Rhode Island facility.
• Perform and monitor critical processes associated with protein purification while following Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs) and batch records.
• Perform in-process sampling of drug substance applying analytical equipment.
• Perform hands-on operations that include inspecting and installing single use components, chromatography operations, UF/DF operations, sample analysis, drug substance fill operations and breaking down vessels.
• Perform technical writing to draft and revise documents such as Manufacturing Procedures, Deviations, Safety Reporting, and Equipment logs.
• Conduct basic troubleshooting and assist in the review of documentation for assigned functions.
• Opportunities to participate in cross-functional teams to expand technical background in the bio-technologies industry.
• Identify, recommend and implement improvements related to CAPAs or Continuous Improvement initiatives.
• Maintaining an inspection ready work space.
• Organizing and maintaining material inventory in the manufacturing space.
• Collaborating with multiple computer systems (Delta V/EBRs) simultaneously to complete operations or troubleshoot issues on the floor.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED