Modeling Data Scientist

HOW MIGHT YOU DEFY IMAGINATION?

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.

Modeling Data Scientist

Job Summary

The Data Scientist is responsible for engineering activities required for development / qualification / and transfer of in-silico models for combination products, devices, primary container, and secondary packaging components, as required. This individual shall have the ability to work on multiple projects at one time that may involve either new or changed product, process, tooling or equipment introduction to improve product quality and reliability.

Responsibilities:

• Develop in-silico modeling to support development and life-cycle management of combination products and associated DP packaging.

• Implement projects per CPO (Combination Product Operations) and company procedures to ensure projects are completed on schedule and within established budget.

• Apply core engineering principles to develop in-silico models for medical device and combination product systems.

• Implement in-silico models in commercial and proprietary software and deploy models to internal users

• Lead and complete experimentation to support in-silico model qualification.

• Provide expert support in the design or redesign of tools and/or equipment required for model qualification.

• Provide expert support for investigations as well as new process development required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving).

• Ensure that qualification parameters are met for in-silico modeling performance requirements per the intended use.

• Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.

• Generate procedures vital to support department and new product equipment.

• Provide expert training to individuals in the operation and maintenance of modeling assets.

• Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams). Supervise work of support staff during development and manufacture of system.

• Develop and maintain coordinated timelines collecting appropriate multi-functional details and work which are aligned with the functional and project work

• Network with manufacturing, quality and regulatory organizations both internal and external to Amgen

• Facilitate robust horizontal communication to ensure all functions are aware of changes in work and impacts to risk.

• Proactively identify issues and/or risks and develop mitigation options to resolve or call out efficiently.

• Integrate partner/vendor timelines with Amgen timelines as appropriate.

The position will require approximately 10% travel to international locations assisting our development partners during implementation of mechanical engineering methods into their processes.

Basic Qualifications:

• Doctorate Degree OR

• Master's Degree and 3 years of Engineering experience OR

• Bachelor's Degree and 5 years of Engineering experience OR

• Associate's degree and 10 years of Engineering experience OR

• High school diploma/GED and 12 years of Engineering experience.

Preferred Qualifications:

• M.S. or Ph. D. in Mechanical, Aerospace, Mechatronics, Chemical or Biomedical engineering

• Excellent written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment

• Experience with leading technical teams, including setting priorities and leveling resources

• Technical writing experience

• Excellent communication (written and verbal) and organizational skills.

• Experienced with SolidWorks (or other 3D-CAD software)

• Experience with process characterization, scale-up, technology transfer experience, pFMEAs and dFMEAs

• Experience with change controls, deviations, CAPA

• Experience with combination products and device regulatory requirements and medical device development and engineering

• Understanding of the six sigma process, applying Minitab (or other statistical software packages) to tackle statistical problems

• Basic programming skills

• Work history with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing

• Experience with machine controls (PLC, HMI) and vision systems

• Experience with FEA and CFD modeling techniques and commercial structural and fluid dynamics simulation software

• Experience with mathematical / first principles modeling and Monte Carlo simulations

Thrive

Some of the vast rewards of working here

As we work to develop treatments that look after others, we also work to care for our teammates professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, improve your expertise, and improve 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith 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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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.

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.

Amgen requires all staff in the United States, Puerto Rico and Canada 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.