30 days old

Specialist Manufacturing

Amgen
West Greenwich, RI 02817
  • Job Code
    117244460
Amgen

Job ID: R-91964
Location: West Greenwich, RI, US 02817

Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that these molecules become medicines. Many of the technologies we're employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping oncology patients.

The Specialist Manufacturing position is within the Product Lifecycle Management organization at Amgen Rhode Island (ARI), a large-scale mammalian cell biotech manufacturing plant that produces multiple commercial and clinical products. The team is responsible for new product introductions and product re-introductions to Amgen Rhode Island's Manufacturing Facilities (AR5 and AR30) and managing the lifecycle of ARI's product portfolio.

Shift: Monday - Friday Admin Day Shift

Responsibilities:
  • Own and manage change controls.
  • Drive continuous improvements of PLM processes.
  • Partner with manufacturing staff to develop and/or revise manufacturing SOPs to support new product introduction or product re-introductions.
  • Develop and maintain the Bill of Materials for each product manufactured at/ transferred to ARI.
  • Support the development of manufacturing sample plans.
  • Assist in developing and delivering training materials to manufacturing staff to support new product introduction (NPI), product reintroduction (PRI), etc.
  • Coordinate parallel projects and cross functional readiness activities.
  • Support NPI / PRI campaign performance tracking and reporting.

Basic Qualifications
  • Doctorate degree
  • OR
  • Master's degree and 3 years of Manufacturing and Operations experience
  • OR
  • Bachelor's degree and 5 years of Manufacturing and Operations experience
  • OR
  • Associate's degree and 10 years of Manufacturing and Operations experience
  • OR
  • High school diploma / GED and 12 years of Manufacturing and Operations experience


Preferred Qualifications
  • Manufacturing experience in both upstream and downstream operations.
  • Strong project management skills.
  • Technical leadership experience.
  • Experience with Single Use Systems (SUS)
  • Strong understanding of manufacturing equipment and processes.
  • Experience with SAP and MES.
  • CFR and Regulatory knowledge, Ability to interpret and apply GMP knowledge.
  • Strong analytical and experimental design skills.
  • Excellent verbal and written communication skills.


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.

PI117244460

<b>Amgen</b><br/><br/><b>Job ID: </b>R-91964<br/><b>Location: </b>West Greenwich, RI, US 02817<br/><br/>Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that these molecules become medicines. Many of the technologies we're employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping oncology patients.<br><br>The Specialist Manufacturing position is within the Product Lifecycle Management organization at Amgen Rhode Island (ARI), a large-scale mammalian cell biotech manufacturing plant that produces multiple commercial and clinical products. The team is responsible for new product introductions and product re-introductions to Amgen Rhode Island's Manufacturing Facilities (AR5 and AR30) and managing the lifecycle of ARI's product portfolio.<br><br>Shift: Monday - Friday Admin Day Shift<br><br>Responsibilities:<br><ul><li>Own and manage change controls.</li><li>Drive continuous improvements of PLM processes.</li><li>Partner with manufacturing staff to develop and/or revise manufacturing SOPs to support new product introduction or product re-introductions.</li><li>Develop and maintain the Bill of Materials for each product manufactured at/ transferred to ARI.</li><li>Support the development of manufacturing sample plans.</li><li>Assist in developing and delivering training materials to manufacturing staff to support new product introduction (NPI), product reintroduction (PRI), etc.</li><li>Coordinate parallel projects and cross functional readiness activities.</li><li>Support NPI / PRI campaign performance tracking and reporting.<br></li></ul><br><b>Basic Qualifications</b><br><ul><li>Doctorate degree</li><li>OR</li><li>Master's degree and 3 years of Manufacturing and Operations experience</li><li>OR</li><li>Bachelor's degree and 5 years of Manufacturing and Operations experience</li><li>OR</li><li>Associate's degree and 10 years of Manufacturing and Operations experience</li><li>OR</li><li>High school diploma / GED and 12 years of Manufacturing and Operations experience</li></ul><br><br><b>Preferred Qualifications</b><br><ul><li>Manufacturing experience in both upstream and downstream operations.</li><li>Strong project management skills.</li><li>Technical leadership experience.</li><li>Experience with Single Use Systems (SUS)</li><li>Strong understanding of manufacturing equipment and processes.</li><li>Experience with SAP and MES.</li><li>CFR and Regulatory knowledge, Ability to interpret and apply GMP knowledge.</li><li>Strong analytical and experimental design skills.</li><li>Excellent verbal and written communication skills.</li></ul><br><br>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.<br><br>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.<br><br>Join Us <br> <br> 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. <br> <br> 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. <br> <br> 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. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/r7EM2gHD6gJzc2p4fz2pW"> <p>PI117244460</p>

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Posted: 2020-01-18 Expires: 2020-02-18

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Specialist Manufacturing

Amgen
West Greenwich, RI 02817

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