Process Development Senior Engineer

e within ASM Process Development for cell culture commercial process support.

• Act as Drug Substance Team Leader within the global Product Development Team (PDT); providing stewardship of product lifecycle and process improvement. This is a global role that interacts with other experts in the areas of Drug Product, Regulatory Affairs, Quality, Business Operations, Supply Chain, and Attributes Sciences.

• Lead complicated investigations independently, providing concise communications to teams and leadership

• Integrate trends, data and information into plans, deliverables and recommendations

• Manage key projects to deliver site goals while meeting quality, schedule, and cost objectives.

• lead productivity projects, process optimization, and product life cycle management.

• Collaborate with cross-functional teams and network drug substance teams to resolve process challenges by applying advanced technical principles and concepts for troubleshooting.

• Apply best practices to leverage data for more proactive and predictive approaches.

• Support regulatory filings, audits and inspection, and other CMC activities (e.g author and review regulatory submissions and responses to questions as required).

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Win

What we expect of you

Basic Qualifications

• Doctorate degree OR

• Master's degree and 2 years of directly related experience OR

• Bachelor's degree and 4 years of directly related experience OR

• Diploma and 8 years of directly related experience

• In depth cell culture process knowledge, including single-use technologies and harvest technologies

• Good understanding of process characterization and process scale up to resolve technical issues observed during transfer / manufacturing at large scale.

• Experienced in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production

• Experienced in Technology Transfer of new process and technology to commercial site.

• Strong communication skills (technical writing and verbal communication/presentation)

• Problem solving skills requiring the application of strong scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach

• Familiarity with documentation in a highly regulated environment

• Ability to independently determine when additional resources are required to solve problems

• Ability to provide solutions to a large variety of technical problems

• Able to lead small team and lead projects

Thrive

What you can expect of us

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.

• Vast opportunities to learn and move up and across our global organization

• 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

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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Equal Opportunity Statement

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

We will ensure that individuals with disabilities are provided a 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 an accommodation.

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