Associate Manufacturing Days (A Shift) - West Greenwich, RI
About The Position
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. 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).
Requirements
- High school/GED + 2 years of manufacturing or operations work experience OR Associate’s + 6 months of manufacturing or operations work experience OR Bachelor’s Degree in a related field
- Ability to interpret and apply GMP knowledge
- Understanding of analytical methods for manufacturing area
- 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
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
- Demonstrated technical writing capability
- Experience with Delta V
- Experience with lab equipment/testing
Responsibilities
- Perform operations in Manufacturing (AR30), specifically in downstream operations.
- 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.
- Identify, recommend and implement improvements related to CAPAs or Continuous Improvement initiatives.
- Maintain an inspection ready work space.
- Organize and maintain material inventory in the manufacturing space.
- Collaborate with multiple computer systems (Delta V/LIMS/EBRs) simultaneously to complete operations or troubleshoot issues on the floor.
- Participate in cross-functional teams to expand technical background in the bio-technologies industry.
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
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
