Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

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

Live

What you will do

Let’s do this! Let’s change the world!

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

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.

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.

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 Amgen’s entire spectrum.

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.

Areas of Responsibility:

Development and Production:

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

• 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

• 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

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

• Large and small molecules

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

Planning and Strategy:

• 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

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

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

• 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

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

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

Staffing and Support:

• 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

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

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

Win

What we expect of you

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

Basic Qualifications:

Doctorate degree

Or

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

Or

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

Or

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

Or

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

Preferred Qualifications:

• Master’s or PhD degree in engineering, life sciences, chemistry or other applicable sciences

• Master’s in Business Administration (MBA) with 2 or more years applying concepts in technical function

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

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

• 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

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

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

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

Thrive

Some of the vast rewards of working here

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.

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

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

• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now for a career that defies imagination

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

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