Specialist Pilot Plant

Profile

HOW MIGHT YOU DEFY IMAGINATION?

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Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

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Live

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What you will do

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Lets do this! Lets change the world!

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We are seeking a Pilot Plant Specialist to join the Business Operations Team at Amgens Pilot Plant in West Greenwich, Rhode Island, that supports ARI PEL and AMA SUL. The successful candidate will be responsible for the Pilot Plants Business Performance Management, Long Range Planning, Raw Material Management, Budgeting, GMP Project Management, and overall logistical support for the Pilot Plant Network production areas.

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You will support plant resources and staff to ensure area and plant execution goals are met, working with our Process Development customers to deliver upon their highest priority needs. The Pilot Plant is a flexible, dynamic development space where Amgen enables GMP alongside development. Employing strong, self-directed leadership skills, you will be responsible for translating bench scale bioprocessing science into manufacturing scale production methods to support preclinical, clinical and commercial activities.

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Amgen Pilot Plants perform frequent piloting of novel process operations, driving technology development and innovation, as well as executing bioprocessing operations. We produce sound, relevant data for the processes Amgen developments at meaningful scales that enable the rapid, successful transfer of our output to more dedicated manufacturing spaces. You will work with the Production Teams, our Clients and the many Support Teams to ensure successful, agile execution.

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The Pilot Plants focus primarily on large molecule cell culture and purification operations, from vial thaw to completion of Drug Substance, and will also support innovation across Amgens entire spectrum.

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The environment is challenging, fast-paced and ever-changing but very rewarding for those that like hands on science and want to make process improvements in a development space.

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Areas of Responsibility:

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Development and Production:

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  Ensure a safe environment where staff, support groups and visitors work in a world class Pilot Plant space

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  Drive the planning, scheduling, budgeting, raw material procurement, and general off the floor enabling activities that allow the production teams to focus on their work scope

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  Lead early engagement with Process Teams through use of platform processing, applied science and engineering subject matter expertise to ensure agile, robust introduction of new processes

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  Work cross-functionally with PD Process Teams across the full spectrum of Process Development including:

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  Large and small molecules

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  Cell culture, microbial fermentation, harvest, purification and chemical synthesis

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Planning and Strategy:

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  Forecast future Pilot Plant resource needs, including expense and capital budgeting, staffing and facility needs; this forward-looking forecast will reflect the best known 1-2 year plan

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  Define an operating strategy that meets the needs of the Pilot Plant customers

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  Work with Amgens supply chain function to maintain an accurate production plan that identifies how demand will be met by capacity

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  Optimize Pilot Plant production execution to allow for fast, flexible processing of multiple product modalities performed in a variety of operating modes with varying durations

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  Ensure that Pilot Plant capabilities and capacity are aligned with PDs current and future needs/expectations, driving expansion or adjustment as Amgen needs evolve

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  Own Pilot Plant Business aspects such as Business Review, KPI reporting, Continuous Improvement monitoring project prioritization

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Staffing and Support:

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  Support the comprehensive scope of their functional area within the Pilot Plant facilities at ARI and AMA, including the engineering support, overall facility state and equipment within the footprint

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  Ensure functional organizational structure design capability that adapts to changing business needs with significant support coming from contracted, external sources

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  Assure necessary area infrastructure is maintained to support a continuous state of readiness for plant operations

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Win

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What we expect of you

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We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.

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Basic Qualifications:

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Doctorate degree

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Or

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Master's Degree and 3 years of biotechnology manufacturing and/or process development environment

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Or

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Bachelor's Degree and 5 years of biotechnology manufacturing and/or process development environment

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Or

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Associate's degree and 10 years of biotechnology manufacturing and/or process development environment

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Or

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High school diploma/GED and 12 years of biotechnology manufacturing and/or process development environment

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Preferred Qualifications:

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  Masters or PhD degree in engineering, life sciences, chemistry or other applicable sciences

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  Masters in Business Administration (MBA) with 2 or more years applying concepts in technical function

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  Project Management certification or 4 or more years managing large projects with diverse teams

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  6 or more years of experience in executing or supporting GMP manufacturing, process development and/or engineering

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  3 or more years functional area leadership that include identifying goals, managing resources, assigning tasks, communicating progress/achievements, developing cost/benefit analysis and negotiating problem resolution

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  2 or more years of experience managing process improvement, utilizing Operational Excellence tools and techniques (Catalyst, Lean Manufacturing, Kaizen, 5S)

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  Excellent communication and negotiation skills, including Sr. Management level communications

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  Experience in a matrixed/global environment at a large company and working in a team driven environment

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Thrive

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Some of the vast rewards of working here

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As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

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  Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

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  A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

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  Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

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Apply now for a career that defies imagination

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Objects in your future are closer than they appear. Join us.

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careers.amgen.com

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rnJoin Us

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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.

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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.

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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.

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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.

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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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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.

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