Job no: 519644
Work type: Non-Tenure-Track Faculty
Location: Main Campus (Gainesville, FL)
Categories: Health Profession, Other
Department:29190000 - MD-NEUROLOGICAL SURGERY

Classification Title:

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

Job Description:

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.

Expected Salary:

Commensurate with Experience

Minimum Requirements:

Ph.D./ M.D., Ph.D.

Preferred Qualifications:

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.

Special Instructions to Applicants:

This position was originally posted under requisition 81850. All previous applicants do not need to reapply.

For consideration, please complete an application and include a cover letter, resume and the names and email addresses of three to five references.

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.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required:Yes

Advertised: 22 Dec 2021 Eastern Standard Time
Applications close: Open until filled