Director, GMP Facility
- Employer
- University of North Carolina at Chapel Hill
- Location
- Chapel Hill, NC
View more
- Administrative Jobs
- Institutional & Business Affairs, Facilities Management & Sustainability
- Employment Type
- Full Time
- Institution Type
- Four-Year Institution
Job Details
Permanent Staff (EHRA NF)
Department:Lineberger Compr Cancer Center-426801
Working Title:Director, GMP Facility
Appointment Type:EHRA Non-Faculty
Position Posting Category:Research Professionals
Salary Range:Dependent on Qualifications and Experience
Full Time/Part Time?:Full-Time Permanent
Hours per Week:40
Vacancy ID:NF0004616
Position ID:20037363
Posting Open Date:11/02/2020
Application Deadline:03/26/2021
Open Until Filled:No
Proposed Start Date:02/01/2021
Position Summary:The Lineberger Comprehensive Cancer Center and the University of North Carolina at Chapel Hill School of Medicine are recruiting an individual to be the facility director for the Good Manufacturing Practice Cellular Expansion Facility. This is a facility with six Class 10,000 clean rooms for the expansion and manipulation of human cells for clinical applications. This individual will provide management and daily oversight to an experienced technical team including the ongoing GMP compliance of our processes, equipment and facilities. Individual will act as an advisor to a robust faculty-led scientific committee on projects and operations. The Center is developing plans for an expansion of this facility over the next 12 months, nearly doubling the capacity of our cellular therapy program. Individual will be involved in the design and of the additional space. Individual will plan for the expansion of the staff and the usage of the facility by internal users as well as external academic and commercial entities. This position also requires on-call and recall to duty as well as availability for interstate and international travel. Duties will include: supervision of technical teams, commissioning and validation of equipment, processes and facilities, ensuring cleanrooms and facilities continually meet operational requirements, managing facility environmental monitoring systems, management and control of equipment and materials, and allocating resources and interacting with internal and external stakeholders. Applicants for this position should have experience with the generation of FDA-compliant cellular products for infusion into patients with cancer, undergoing stem cell transplantation and for therapy for autoimmune or organ failure diseases.
Educational Requirements:BA or BS in Biology, Biochemistry, Chemistry with three to five years GMP experience or PharmD in Pharmacy, MSc in Pharmaceutical Science, PhD in Immunology and or Microbiology or MD degree.
Qualifications and Experience:Skills and experience in working with and managing technical staff, with demonstrable communication skills, time management skills and timely delivery of required deliverables. Successful input into continuous improvement initiatives, demonstrated skills and experience in the isolation of and characterization of immune cells with a particular focus on T-lymphocytes, B-lymphocytes and or NK cells. Post graduate experience qualifications in pharmaceutical or biological sciences, regulatory affairs, project management. Experience in the manufacturing or development of regenerative medicine or immunotherapy cell therapy products; Knowledge and or experience of the code of GMP for Human Blood & Tissues or equivalent frameworks in the US or EU Experience in medicinal agency audits. Familiarity with GMP Vector Production is desirable. Knowledge and experience of ISO 14644 cleanroom requirements in the context of PIC S annex 1 and 13 Cleanroom facility commissioning Validation and commissioning of scientific medical Equipment used in a GMP facility. Able to provide expert consultancy to external parties on cGMP cleanrooms commissioning to PIC S standards.
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, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.
Organization
The nation’s first public university is at the heart of what’s next, preparing a diverse student body to become creators, explorers, innovators and leaders in North Carolina and throughout the world. Carolina’s nationally recognized, innovative teaching, campus-wide spirit of inquiry and dedication to public service continue the legacy that began in 1795 when the University first opened its doors to students.
Here, in one of America's most beautiful college settings, we offer exceptional careers in richly diverse fields. Come explore what UNC-Chapel Hill has to offer you.
Undergraduate Enrollment: 19,117
Graduate/Professional Enrollment: 10,894
Total Student Enrollment: 30,011
Founded: 1789, as the first state university in the United States
Type of Institution: Public, four-year
Undergraduate Admission: 15,961
Graduate/Professional Enrollment: 10,039
Total Student Enrollment: 26,000
Faculty: 3,000
Percentage of faculty who hold Ph.D.s or the highest degrees in their field: 94 percent
Faculty/student ratio: 1/14
Location: UNC is located in the heart of Chapel Hill, the best college town in America! It's a friendly town of about 40,000 in the geographical center of North Carolina. Chapel Hill is at the western point of the Research Triangle, an area of about one million people, comprised of Chapel Hill, the cities of Durham and Raleigh, and the Research Triangle Park, home of many corporate offices and scientific research centers. Carolina is about 30 miles from the state capital, Raleigh, and 20 minutes from Raleigh-Durham International Airport.
Chapel Hill's main street, Franklin Street, borders the campus and offers shops, coffee houses, cafés, movie theaters and houses of worship. The town has a historic district, museum, library, parks, malls, and many recreational facilities.
Origins of Carolina's students: 82 percent of UNC's freshmen are from North Carolina and 18 percent are from out-of-state. Our students come from 42 different states and our international students represent 37 countries.
Size of freshman class: Approximately 3,400
Class size: Barely five percent of undergraduate classes contain more than 100 students; two-thirds of undergraduate classes have fewer than 30 students. Forty-one percent have fewer than 20 students, including First Year Seminars, in which first-year students work closely with professors.
Sports and athletic programs: UNC is an NCAA Division I school with 28 varsity teams. Carolina is the proud home of the Dean Smith Center, Kenan Stadium, Carmichael Auditorium, Koury Natatorium, and many other fine athletic facilities. Students join more than 60 intramural and club sports, which include baseball, bowling, crew, golf, lacrosse, rock climbing, rugby, tae kwon do, and ultimate frisbee. The Student Recreation Center offers weight training, aerobics, stair machines, and all the equipment you would expect to find at a great health club! Carolina offers a newly renovated outdoor pool and indoor pools, a golf course, tennis courts, and the longest zipline in America!
Number of residence halls: Incoming undergraduates will live in one of Carolina's 29 residence halls, which are wired for Internet access and cable television. housing.unc.edu
Scholarships and financial aid: About 40 percent of UNC-Chapel Hill students receive scholarships and/or some form of financial aid. studentaid.unc.edu
Special research institutes: Institute for Research in Social Science, Institute of Outdoor Drama, Morehead Planetarium, Kenan Institute of Private Enterprise, Institute of Government, Institute of African American Research.
Career services: On-campus counseling, job fairs, résumé writing service, internships, placement services. www.unc.edu/depts/career
Technological facilities: Students find multiple uses for Carolina's state-of-the-art technological resources. They can access Carolina's computer services through Academic Technology and Networks, which manages academic computing, e-mail, microcomputing labs, interactive media presentation, video and classroom support, and a help desk. The MetaLab oversees the development of SunSITE, one of the world's busiest digital library and electronic publishing projects.
Students may open e-mail accounts, and many use campus computer resources to construct personal Web pages. Students in residence halls have hardwired network connections to the Internet and cable television in their rooms. At the ATN Training center, students may take classes on software packages and utilities. Computer labs are available for student use all over campus.
Carolina Computing Initiative: Beginning with the freshman class of 2000, undergraduates must purchase laptop computers. The University has arranged for IBM to offer computers at excellent prices. Students, faculty, and staff will enjoy cost savings, higher quality compatible equipment, and better technical support through CCI. www.unc.edu/cci
The Study Abroad program allows students to live and learn in Europe, the Middle East, Asia and the Pacific Rim, Africa, and the Americas. www.unc.edu/depts/abroad
The Honors Program offers special seminars, research programs, and the chance to design your own independent studies. www.unc.edu/depts/honors
Carolina students spend time in public service through student organizations, the Campus Y, the Carolina Center for Public Service, and courses that incorporate community service.
UNC's chapter of Phi Beta Kappa, a national collegiate honor society, is the oldest in North Carolina, dating from 1904. There are many other honorary societies at Carolina.
UNC offers ROTC programs in all branches of national military service.
Through the First Year Seminars program, first year students will understand what it means to study at a premier research university. They will learn from faculty members and share in their research in seminars of no more than 20 students.
Life outside the classroom: More than 370 clubs, teams, and student organizations offer something for everyone! You can choose from among musical and dramatic performing groups, publications, ethnic and religious clubs, the Campus Y and other service organizations, fraternities and sororities, and pre- professional organizations. Whatever your interests, you will find others at Carolina who share them! www.unc.edu/depts/union/student/listintr.htm
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