Senior Associate Manufacturing

Company: Amgen
Location: West Greenwich
Posted on: November 22, 2021

Job Description:

Shift: rotating nights D shift (7pm 7am)Under minimal supervision, the Senior Associate Manufacturing will lead operations in the Perfusion, Production and Harvest Areas per Standard Operating Procedures. Senior Associate will perform and monitor critical manufacturing processes, execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, Deviations, and technical reports. The Senior Associate will provide technical leadership to the team per the direction of the Perfusion, Production and Harvest manager as well as perform complex troubleshooting. Additionally, the Senior Associate may identify, recommend, and implement improvements related to routine functions and participate on Cross-functional teams while representing the Perfusion, Production and Harvest Department.Basic Qualifications:

• Masters degree
• OR
• Bachelors degree and 2 years of Manufacturing or Operations experience
• OR
• Associates degree and 6 years of Manufacturing or Operations experience
• OR
• High school diploma / GED and 8 years of Manufacturing or Operations experiencePreferred Qualifications:
  • Knowledge of large scale cell culture operations
  • 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
  • Written and verbal communication skills
  • Able to demonstrate project management and presentation skills
  • Independent cross functional collaboration
  • Ability to understand, apply and evaluate basic chemistry, biology and physical principles
  • Basic troubleshooting skills on Manufacturing operations and equipment
  • Experience with Delta V, RDs, SIMCA, PI
  • Experience with lab equipment/testing
  • Knowledge of LEAN principlesAmgen 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 peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.Join UsIf 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.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Keywords: Amgen, Warwick , Senior Associate Manufacturing, Other , West Greenwich, Rhode Island