29 days old

2021 Summer Graduate Intern

Amgen
Thousand Oaks, CA 91360
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  • Job Code
    127608338
Amgen

Job ID: R-108523
Location: Thousand Oaks, CA, US

Global Device Regulatory:

Amgen's internship program offers meaningful project experiences that impact patient's lives. We are seeking candidates who are ready to make a positive impact and use their talents to accomplish more than they thought possible.

The interns will apply their science, engineering, and analytical capability to collect, compile, and correlate critical factors' attributing to drug delivery device related drug product approval process including design control, human factors assessment, and FDA submission process.

This work will develop prospect interns with concrete patient centric product insights by working with multi-functional groups together. It will also enable the intern to immerse in the innovate regulatory oversight, product designs, process flows, commercialization, and supply chain excellence to provide patients with favorable experiences in using Amgen's products and to empower patients in charge of their treatment regimen.

Project Description :

There is an unmet need to better understand pediatric device requirements and suitable drug delivery devices for pediatric patient populations, as recognized by the Device Regulatory team through pediatric product development for Aimovig, Repatha, Prolia, Neulasta, and Nplate etc.As the case with drug development, delivery device development for pediatric use generally occur after initial device approval for adults. Historically, devices have rarely been designed specifically for children. Over the past years, only about 10% of drug approvals by the FDA have included devices designed and indicated for children younger than 18 years old.

This summer project proposal will focus on the information collection and understanding of regulatory requirements for successful pediatric device submission to gain market authorizations globally. Multiple steps are planned to achieve this project goal including:
  • Collect current pediatric device landscape in competitive marketplace
  • Assess the challenges and opportunities of these pediatric devices
  • Summarize regulatory requirements for pediatric devices

The survey of pediatric device landscape will consider both Amgen's existing portfolios such as neurological, cardiovascular, osteoporosis treatment, and Amgen's future medicines such as BiTE's, CAR-T and oncology pediatric device applications. The learning of pediatric devices may venture into the treatment of Type I diabetes, growth hormone deficiency, and severe allergy. In additions to electronic autoinjectors and pen injectors, the regulatory pathways of pulmonary delivery devices and transdermal devices designed for pediatric patients may also be in scope.

Basic Qualifications
  • 18 years or older
  • Graduated with a Bachelor's degree from an accredited college or university with a 3.0 minimum GPA or equivalent
  • Completion as a first-year graduate student before internship starts or currently enrolled in a Master's program or PhD program from an accredited college or university
  • Must not be employed at the time the internship starts
  • Possess U.S. citizenship, permanent legal residence, or unrestricted work authorization in the U.S.

Preferred Qualifications:
  • Educational Disciplines Sought: Degree Concentration(s)in Regulatory Affairs, PharmD, Clinical Research, Medical Device Research, Human Factor Engineering, Biomedical Engineering, Computer Engineering, Electrical Engineering, Mechanical Engineering, Chemical Engineering, Materials Science and Engineering.
  • Ability to learn independently, enjoy doing research, and interested in a variety of topics
  • Tenacity to thrive in a high-performance culture
  • Dedicated individual with strong digital capability and passion to serve patients
  • Excellent oral/written communication skills and interpersonal skills
  • Disciplined time management, decision-making, and organizational skills
  • Ability to apply research findings, capture information, interpret and analyze results
  • Strong project management skills, proficiency in logistic planning
  • Ability to think critically, actively anticipate problems and propose solutions
  • Work effectively/collaboratively across teams
  • Strong hands-on can-do attitude and relentless passion to improve human life

Open Role Title (if intern conversion is desired):
  • Associate in Device Regulatory (B.S.)
  • Senior Associate in Device Regulatory (M.S.)

Join Us:

Amgen internship program is committed to providing future scientists with an enriching environment to inspire innovation that will contribute to the development of human therapeutics. We are seeking a highly motivated graduate candidate. The successful applicant will perform independent research within the context of a highly collaborative environment and with access to state-of-the-art technologies and resources.

Each internship position will provide strategic, operational and project management support for a business organization in an area such as Research & Development, Compliance, Global Commercial Operations/Marketing, Finance, Operations, and more! This unrivaled opportunity provides learning on the inner workings and cross-functional aspects of running a multi-billion dollar business.

The program, sponsored by senior leaders at Amgen, provides robust work experiences across many functions and your participation and successful completion of the CDP summer internship experience will present the opportunity to be evaluated for a full-time offer to join the CDP rotational program in 2022 post-graduation. Full-time opportunities are dependent on available positions and an evaluation of internship performance. Limited relocation housing and/or miscellaneous allowance may be available for eligible candidates.

Working 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.

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. Join us to make a difference in the lives of others and work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

The learning of pediatric devices may venture into the treatment of Type I diabetes, growth hormone deficiency, and severe allergy. In additions to electronic autoinjectors and pen injectors, the regulatory pathways of pulmonary delivery devices and transdermal devices designed for pediatric patients may also be in scope.

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.



PI127608338
Posted: 2020-12-19 Expires: 2021-01-20

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2021 Summer Graduate Intern

Amgen
Thousand Oaks, CA 91360

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