GMP Quality Manager - Preston A. Wells Center for Brain Tumor Therapy and the UF Brain Tumor
Scientific Laboratory Manager
The Good Manufacturing Practices (GMP) Laboratory within the University of Florida's Department Of Neurosurgery is seeking a Scientific Laboratory Manager to serve as the GMP Quality Manager. This is a highly specialized role that will be responsible for coordinating the timely testing of clinical trial gene and cell therapy production lots and ensure timely development and qualification of Quality Control assay methods and the translation of protocols from research to the current Good Manufacturing Practices (cGMP) testing laboratory.
Responsibilities of this position include, but are not limited to:
Management of quality control activities of the current Good Manufacturing Practices (cGMP) Quality Control laboratory:
• Reviews all test results.
•Conducts all Out Of Specification (OOS) failure investigations.
• Troubleshoots assay problems.
• Coordinates testing with production runs and release schedules.
• Interacts with the Associate Director of Operations, Assistant Director of Manufacturing and sponsors to coordinate timely testing of reagents and products within the Quality Control Laboratory.
• Prepares progress reports and final reports on results of testing, including oral presentations.
• Provides technical supervision to staff to ensure quality protocols are followed.
Record and Protocol Management
• Manages qualification of the developed assays for use in the QC Lab by writing protocols, coordinating appropriate experiments and writing qualification reports.
• Troubleshoots assay methodology issues and arranges 005 experimentation.
• Works with the Quality Management Department including writing of Standard Operating Procedures (SOPs), QC Reagent Preparation Records (QCRP), Testing Records (TRs), Release Specification documents (RS) and Certificates of Analysis (CoA) and approves in writing these documents.
• Develops and writes stability protocols for various products and reagents manufactured in the Facility. Maintains stability data.
• Maintains accurate records, including data, deviations and laboratory budget, and file management. Technically reviews data, writes reports, and assist in campaign and project planning and time-line development together with the Operations and Sponsors.
• Provides mentorship and technical direction to GMP laboratory staff, including in-service training on related Manufacturing and Quality Control topics. May be assigned to one-on-one mentorship and training tasks for onboarding and retraining purposes.
• Acts as resource for GMP staff with the implementation of protocols related to both Manufacturing and Quality Control.
• Serves on internal committees for the creation of Standard Operating Procedures (SOPs), QC Reagent Preparation Records (QCRP), Testing Records (TRs), Release Specification documents (RS) and Certificates of Analysis (CoA) SOPs, workflows, and metrics. Collaborates with leadership and support staff to implement and change policies and/or procedures.
Coordinates and assesses assay methodologies for the testing of clinical grade cell and gene therapy drug substances and drug products for use in the cGMP compliant QC Laboratory of the Powell Gene Therapy Center.
• Flow cytometery, biological functional assays, cytokine quantification assays, infectious center assays, other tissue culture assays, PAGE, ELISA, dot blot, western hybridization, Real-time PCR, and other molecular biology methods.
Bachelor's degree in an appropriate area and two years of relevant experience. Appropriate college course work may substitute at an equivalent rate for the required experience.
The ideal candidate will have the following qualifications:
• Bachelor’s degree in an appropriate area of specialization and two years of GMP Quality Control experience, appropriate college course work may substitute at an equivalent rate for the required experience.
• Experience with the drafting SOPs, Test Records and Product Release Specifications
• Experience with managing QA/QC out of specification investigations and routine process and testing deviations
• Strong working knowledge of cGMP Quality Control biologics manufacturing processes testing and equipment and regulatory requirements
• Experience with the development of investigational new drug (IND) CMC submissions
• Experience in managing and driving QC Testing process improvements
• Strong auditing experience
• Must have excellent verbal, written and interpersonal communication skills
Special Instructions to Applicants:
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.
This is a time limited position.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required: Yes
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