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24 days old

Intern - Regulatory Affairs, CMC

Kelly Services
Santa Monica, CA 90407
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as an **Intern - Regulatory Affairs, CMC** at a prestigious Fortune 500 company working in **Santa Monica** **.**





**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.





**Job Title: Intern - Regulatory Affairs, Chemistry, Manufacturing and Controls**





2019 Intern Pay Rates Total Hourly Bill Rate Total Cost (12 weeks)

Intern I BS / BA Sophomore $14.66 - 17.30

BS / BA Junior $16 - 18.88

BS / BA Senior $17.33 - 20.45

Intern II MS / MBA $28.66 - 33.82

Intern III PharmD / PhD $32 - 37.76




**Responsibilities**

Intern - Regulatory Affairs, Chemistry, Manufacturing and Controls


A leader in engineered T-cell therapies, is offering a Regulatory Affairs (RA) internship opportunity. In this role, you will learn about the role of a Regulatory Affairs professional in Regulatory Affairs, Chemistry, Manufacturing and Controls (RA-CMC).


RA-CMC provides the strategy and knowledge needed to ensure that chemistry, manufacturing and control (CMC) practices are carried out in accordance with the requirements of regulatory bodies, such as the FDA (US Food and Drug Administration) and EMA (European Medicines Agency). This function also provides support for all regulatory aspects of CMC and assures optimal functioning of internal and external interfaces between RA-CMC and stakeholders for activities across all product development projects. Additionally, RA-CMC closely interacts with multiple functions to create high quality regulatory submissions that support product development strategy. The RA-CMC internship will provide the opportunity for interested individuals to develop an understanding of regulations and guidance as they relate to development and global lifecycle management of the Module 3 (CMC) portion of dossiers for cell therapy clinical or commercial products. The intern will also learn about the role and responsibilities of key functions that work closely with RA-CMC (Quality, Manufacturing, Process Development, and Supply Chain). The intern will receive mentorship from senior RA-CMC managers and have an opportunity to support the development of one or more CMC supplements for company products.


After 3 months with RA-CMC, an optional 3-month extension may be offered in the same or different RA discipline based on candidate interest, qualifications and business need, resulting in a total maximum internship duration of 6 months.


**Eligibility and Qualifications** :

Must be enrolled in the Fall Semester at an accredited university/college after the completion of the internship (certification programs do not qualify) or graduated within 1 year of the start of the internship

Graduate or undergraduate degree concentration(s) in biologic science, regulatory science, pharmaceutical sciences, bioengineering or similar related degree programs

Must be available to work full time (40 hours/week) for a minimum consecutive 3 month internship with flexible start in June or July

Must be authorized to work in the U.S. without sponsorship

Must be able to finance own relocation/housing, if not local

Excellent verbal and written communication skills

Proficient in Microsoft Office and similar systems (e.g., MS Word, MS PowerPoint, Adobe)

Flexible, able to work in a fast-paced, rapidly-changing environment

Proactive and solution-oriented

Familiarity with regulatory requirements associated with control and manufacturing of biologics is a plus

Understanding of scientific principles

Excellent interpersonal skills




**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com at http://www.kellyservices.com/ **.**



**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**



**Kelly Services is an Equal Opportunity Employer**










**Why Kelly** **** **?**



Kelly Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2020-05-08 Expires: 2020-06-08

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Intern - Regulatory Affairs, CMC

Kelly Services
Santa Monica, CA 90407

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