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 but is not limited to developing training, SOPs, electronic batch records, job hazards analysis, and standard work. Additionally, Associate will be asked to participate in factory acceptance testing and commissioning and qualification of new process equipment. During this startup phase, international (to Singapore) and local travel may be requested for a period of up to 6 weeks duration to support training and equipment qualification.
After the facility startup phase (up to one year), the Associate will be expected to join a shift team working a 12-hour shift. The shift pattern will be either a 7AM-7PM or a 7PM – 7AM structure with a rotation covering 7 days per week.
Once the facility is in production, the Associate will be responsible to perform operations in the Manufacturing area under general supervision. 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. Associate will also perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams and represent Manufacturing. Employee may also have the responsibility of owning NC/CAPA’s. In addition, Associate may identify, recommend, and implement improvements related to routine functions.
There are multiple openings for this position.
Basic Qualifications :
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 single-use Bio-manufacturing technology
CFR and Regulatory knowledge
Knowledge of lab equipment and computers
Basic statistical mathematical skills
Ability to interpret and apply GMP knowledge
Understanding of analytical methods for manufacturing area
Ability to demonstrate 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
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.