Amgen Associate Manufacturing in Rhode Island, Rhode Island
The initial focus of this role will be part of the AR30 startup team on Admin Day shift to prepare the facility for Operational Readiness. This includes and not limited to support interviewing of manufacturing operations team, develop training, SOPs, electronic batch records, job hazards analysis, and standard work. Participate in Factory acceptance test and also commissioning and qualification of process equipment.
After the facility startup phase (up to one year), the successful incumbent will be expected to join a shift team working a 12-hour rotating night shift. The shift pattern will be a 7PM – 7AM structure with a rotation covering 7 days per week.
The rotating 12-hour night shift offers several benefits, with an average of 14 days on shift per month with every other weekend off. In addition, the night shift is eligible for a shift differential and any Sundays worked receive Premium pay.
There are multiple openings for this position.
Under general supervision, Associate will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs). Associate will perform and monitor critical processes, execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports. Employee will also perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams and represent the Purification group. Employee may also have the responsibility of owning NC/CAPA’s. In addition, employee may identify, recommend, and implement improvements related to routine functions.
Basic Qualifications :
Bachelor's degree or completed by June 2019
Associate's degree and 4 years of Manufacturing or Operations experience
High School diploma/GED and 6 years of Manufacturing or Operations experience.
Preferred Qualifications :
Knowledge of large-scale Purification operations, chromatography, TFF, aseptic processing, etc.
CFR and Regulatory knowledge
Knowledge of WIP lab equipment and computers, with LIMS access
Basic statistical mathematical skills
Ability to interpret and apply GMP knowledge
Understanding of analytical methods for manufacturing area
Ability to demonstrate technical writing capability with Trackwise access
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 Purification equipment
Experience with Delta V, RD’s
Experience with lab equipment/testing
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 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.