Director, GMP Facility

Job description

Position Type:

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.

 

 

 

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Job No:
Posted: 3/2/2021
Application Due: 3/27/2021
Work Type: Full Time
Salary: