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27 days old

Cryogenic Storage Operations Associate

Kelly Services
Cleveland, OH 44101
WE ARE SEEKING: A Clinical Development and Product Operations Associate to work in a dynamic, high performing, cross-functional team, that is responsible for late stage development and technical transfer of manufacturing processes used in the production of novel, allogeneic cell therapy products. The Associate will manage technical and operational investigational product (IP) related activities, both internally and at external clinical institutions, to ensure successful execution of ongoing investigational clinical trials. This position will report to the Sr. Manager, Clinical Manufacturing and Supply. In this role, primary responsibilities will be to:




+ Interact with the internal team, Clinical Research Organizations (CROs) and clinical site end users to verify that IP is stored, prepared and administered according to clinical trial specifications;

+ Provide technical support and training to clinical trial staff on proper storage, handling and preparation of clinical trial products;

+ Create and manage SOPs, controlled documents and training materials for clinical end users;

+ Manage the investigation and resolution of events occurring at clinical sites using established quality system elements (deviation, CAPA, change control, etc.);

+ Coordinate and perform internal and external process and equipment qualifications/validations as necessary;

+ Assist in the management of cold chain logistics from manufacturer to clinical site end users; and

+ Ability to travel domestically and internationally to clinical sites (10-20%), as needed.



WE ARE OFFERING: A competitive salary, generous benefit package including medical, dental, disability, life insurance, equity incentives and bonus structure which will be discussed with qualified candidates.


EDUCATION/EXPERIENCE:


+ B.S. in the biological sciences or related field;

+ Experience with cryogenic storage equipment, such as liquid nitrogen freezers and temperature monitoring systems;

+ At least 2-3 years of experience working in a regulated environment and knowledge of quality systems;

+ Experience with aseptic technique and cell/biological product processing; and

+ Clinical trial experience a plus.








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



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**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: 2019-11-18 Expires: 2019-12-19

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Cryogenic Storage Operations Associate

Kelly Services
Cleveland, OH 44101

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