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Program Director of Good Manufacturing Practice & Assistant/Associate/Full Scientist (81850)

Employer
University of Florida
Location
Florida, United States
Salary
Salary Not Specified
Date posted
Sep 16, 2021


The Department of Neurosurgery at the University of Florida is seeking applications for a Director of Operations for the Good Manufacturing Practice (GMP) Facility and single mission track Assistant, Associate, or Full Scientist position to join the faculty. This faculty appointment will be with the Department of Neurosurgery, but will be housed within the Clinical and Translational Science Institute (CTSI). This is a non-tenure track position.

Operations in MBI and C&G Facilities.
  • Coordinate Facilities Operation, Cleaning and Maintenance with GMP Facility Manager.
  • Coordinate QC Testing Activities with QC Manager.
  • Coordinate Quality Management Activities with QM Manager.
  • Coordinate Manufacturing Activities with Manufacturing Manager.
Project Lead for New Project Development.
  • New Equipment Installation and Validation.
  • New Manufacturing Process Development with Sponsor.
  • New Test Method Development and Qualification with Sponsor.
  • New Quality and Regulatory Support with Sponsor.
Budget and Personnel.
  • Assist Appropriate Departmental/Center Fiscal Groups with Budgets.
  • Assist Appropriate Departmental/Center HR Groups with Personnel.
Ph.D Education and at least 5 years' experience in GMP Operations.

Fundamental Understanding of cGMP Regulations.
Fundamental Understanding of Investigational New Drug Applications/Ongoing Chemistry, Manufacturing, Controls (CMC) amendments/annual reports.
At least 3 years' experience with project management.

Experience with GLP and GCP regulations preferred but not required.

To apply, please attach a cover letter, CV and at least 3 professional references with submission of application.

The Search Committee will accept applications until the position is filled. Applications will be reviewed starting as soon as possible after the posting date.

Final candidate will be required to provide official transcript to the hiring department upon hire. A transcript will not be considered “official” if a designation of “Issued to Student” is visible. Degrees earned from an education institution outside of the United States are required to be evaluated by a professional credentialing service provider approved by National Association of Credential Evaluation Services (NACES), which can be found at http://www.naces.org/ .

The University of Florida is an equal opportunity institution dedicated to building a broadly diverse and inclusive faculty and staff.

The University of Florida is An Equal Employment Opportunity Institution. If an accommodation due to a disability is needed to apply for this position, please call 352/392-2477 or the Florida Relay System at 800/955-8771 (TDD). Hiring is contingent upon eligibility to work in the US. Searches are conducted in accordance with Florida's Sunshine Law.

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The University of Florida is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

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