Amgen

Associate Manufacturing

Employer
Amgen
Location
Rhode Island, RI, US
Posted
Sep 17, 2019
Ref
R-83597
Required Education
High School or equivalent
Position Type
Full time
Job Description

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 day shift. The shift pattern will be a 7AM - 7PM 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

Associate's degree and 4 years of Manufacturing or Operations experience

OR

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
  • Mechanical ability/expertise
  • 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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.