Masters degree in an appropriate area and seven years of relevant experience.
Job Description:
QC Laboratory Operations & Compliance
Lead day-to-day operations of the QC laboratory in support of in-process release and stability testing for GMP clinical materials.
Author revise and implement SOPs specifications forms protocols reports and laboratory documentation to maintain a robust and scalable QC system.
Review and approve laboratory records test results logbooks worksheets protocols reports and other controlled documentation for completeness accuracy and compliance.
Lead or support laboratory investigations related to OOS OOT deviations atypical results excursions and CAPA
Support method qualification transfer validation readiness and new assay implementation as programs evolve.
Team Leadership & Lab Oversight
Supervise QC staff including training scheduling workload prioritization performance management and technical development.
Support the environmental monitoring program for classified GMP spaces including scheduling trend review documentation and collaboration with Facilities and QA on excursions and corrective actions.
Oversee laboratory equipment readiness maintenance calibration qualification and troubleshooting coordination to ensure an inspection-ready QC operation.
Cross-Functional Collaboration
Partner closely with Manufacturing Facilities and Quality Assurance to align testing priorities withproduction schedules investigations batch disposition needs and facility monitoring requirements.
Expected Salary:
$96350-$110700
Required Qualifications:
Masters degree in an appropriate area and seven years of relevant experience.
Preferred:
Working knowledge of cGMP GLP GDP deviation management investigations CAPA change control and data integrity principles.
Minimum 5-8 years of relevant experience in a GMP-regulated biopharmaceutical biotechnology cell therapy gene therapy or CDMO environment including progressive QC laboratory responsibilities.
Prior experience supporting cell therapy gene therapy immunotherapy or other advanced therapy products.
Hands-on experience with cell-based assays flow cytometry PCR/qPCR molecular assays sterilityrelated testing support and/or potency-related assay
Experience with environmental monitoring in classified cleanroom environments.
Experience with method transfer qualification validation support and assay lifecycle management.
Prior experience supervising or mentoring laboratory personnel
Excellent attention to detail and commitment to data integrity; Strong written and verbal 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 an Equal Employment Opportunity Employer.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required:
Yes
Required Experience:
Manager
Classification Title:Research & Development ManagerClassification Minimum Requirements:Masters degree in an appropriate area and seven years of relevant experience.Job Description:QC Laboratory Operations & ComplianceLead day-to-day operations of the QC laboratory in support of in-process release an...
Classification Title:
Research & Development Manager
Classification Minimum Requirements:
Masters degree in an appropriate area and seven years of relevant experience.
Job Description:
QC Laboratory Operations & Compliance
Lead day-to-day operations of the QC laboratory in support of in-process release and stability testing for GMP clinical materials.
Author revise and implement SOPs specifications forms protocols reports and laboratory documentation to maintain a robust and scalable QC system.
Review and approve laboratory records test results logbooks worksheets protocols reports and other controlled documentation for completeness accuracy and compliance.
Lead or support laboratory investigations related to OOS OOT deviations atypical results excursions and CAPA
Support method qualification transfer validation readiness and new assay implementation as programs evolve.
Team Leadership & Lab Oversight
Supervise QC staff including training scheduling workload prioritization performance management and technical development.
Support the environmental monitoring program for classified GMP spaces including scheduling trend review documentation and collaboration with Facilities and QA on excursions and corrective actions.
Oversee laboratory equipment readiness maintenance calibration qualification and troubleshooting coordination to ensure an inspection-ready QC operation.
Cross-Functional Collaboration
Partner closely with Manufacturing Facilities and Quality Assurance to align testing priorities withproduction schedules investigations batch disposition needs and facility monitoring requirements.
Expected Salary:
$96350-$110700
Required Qualifications:
Masters degree in an appropriate area and seven years of relevant experience.
Preferred:
Working knowledge of cGMP GLP GDP deviation management investigations CAPA change control and data integrity principles.
Minimum 5-8 years of relevant experience in a GMP-regulated biopharmaceutical biotechnology cell therapy gene therapy or CDMO environment including progressive QC laboratory responsibilities.
Prior experience supporting cell therapy gene therapy immunotherapy or other advanced therapy products.
Hands-on experience with cell-based assays flow cytometry PCR/qPCR molecular assays sterilityrelated testing support and/or potency-related assay
Experience with environmental monitoring in classified cleanroom environments.
Experience with method transfer qualification validation support and assay lifecycle management.
Prior experience supervising or mentoring laboratory personnel
Excellent attention to detail and commitment to data integrity; Strong written and verbal 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 an Equal Employment Opportunity Employer.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
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Monthly Salary:
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