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Good Manufacturing Practices Specialist

Company: University of North Carolina at Chapel Hill
Location: Chapel Hill
Posted on: July 3, 2019

Job Description:

Posting Information Position Information Position Type Permanent Staff (SHRA) Is this an internal only recruitment? No Position Title Research Specialist - Contributing Working Title Good Manufacturing Practices Specialist Position Number 20032458 Vacancy ID P010099 Budgeted Hiring Range $43,000 - $48,000 Pay Band Information To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet . Salary Grade Equivalent 65/GN08 Full-time/Part-time Permanent/Time-Limited Full-Time Permanent If time-limited, estimated duration of appointment Hours per week 40 Work Schedule Mon-Fri; 8:30 am - 5:00 pm Department Name and Number Lineberger Compr Cancer Center-426801 Date First Posted 05/08/2019 Closing Date 07/05/2019 Position Location Chapel Hill, NC Position Posting Category Research Professionals Position Summary Information Department Description The UNC Lineberger Comprehensive Cancer Center, founded in 1975, is one of 47 National Cancer Institute (NCI)-designated comprehensive cancer centers in the country. The Center's mission is to reduce cancer occurrence and death in North Carolina and the nation through research, treatment, training and outreach. Equal Opportunity Employer The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran. Position Description The person in this position will be responsible for the production of human cellular therapy products intended for administration to patients enrolled in clinical trials following all regulatory requirements to ensure compliance with federal and state statutes. Cell products may be from patients with infectious diseases including HIV. Production will be guided by specific procedures and accurately documented in completely filled out manufacturing records. Sampling and analysis for quality control purposes, product and sample inventory storage, transportation and shipping of product/samples, materials tracking and management, and data collection/reporting are additional functions in this position. Person will take lead in developing SOPs and collaborate with investigators in translation of bench-scale techniques to large-scale production. Person will work closely with team members to assure compliance with regulatory requirements. Minimum Education and Experience Requirements Bachelor's degree in a discipline related to the area of assignment; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions. Essential Skills, Knowledge and Abilities Knowledge and experience in aseptic technique and manual mammalian cell culture. Willing to work in cleanroom environment with potentially infectious materials. Demonstrated and extensive skills in the operation and troubleshooting of complex laboratory machines (e.g. automated immunomagnetic separation devices). Proficiency with MS Office. Preferred Qualifications Minimum of Bachelor's Degree in biological or chemical science (or equivalent) and two years of experience in cellular therapy production highly desired. Prior experience working with transducing retrovirus for manufacturing of human cellular therapy products in a Good Manufacturing Practice (GMP) environment is highly desired. Required Licenses/Certifications Special Physical and Mental Requirements Position/Schedule Requirements Laboratory Position Attributes Stimulus/ARRA Funded No Quick Link Contact Information Office of Human Resources Contact Information If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at (919) 843-2300 or send an email to Please note: The Office of Human Resources will not be able to provide specific updates regarding position or application status. Applicant Documents Required Documents Curriculum Vitae / Resume List of References Optional Documents Cover Letter Posting Supplemental Questions Required fields are indicated with an asterisk (). Please select the response below that best describes your experience/education for the Research Specialist position. Bachelor's, Master's or Doctoral degree in a discipline related to the area of assignment. Associate's degree in a discipline related to the area of assignment and 2 years related experience. Combination of related post-high school education and experience to equal at least 4 years of experience in a closely related field. (ex: 1 year towards a related degree and 3 years of related experience). High School diploma/GED and at least 4 years of related experience Did not complete high school but have a combination of high school education and experience to equal at least 8 years (ex. 3 years of high school and 5 years of experience). None of the above Describe your experiences working in a facility that utilizes Good Manufacturing Practices (GMP). (Open Ended Question) Please describe your experience in the manufacture/production of human cellular therapy products. (Open Ended Question) Are you willing to work in a cleanroom environment? Yes No Are you available to work variable hours as required? Yes No

Keywords: University of North Carolina at Chapel Hill, Chapel Hill , Good Manufacturing Practices Specialist, Other , Chapel Hill, North Carolina

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