RESEARCH PROGS/SVCS, AST DIR 2
RESEARCH PROGS/SVCS, AST DIR 2, Quality Control
Commensurate with education experience.
If other work location
This position is located in Progress Corporate Park in Alachua, FL.
The incumbent serves as the Florida Biologix Quality Control Director, reporting to the Associate Director, Center of Excellence for Regenerative Health Biotechnology. The incumbent ensures that the QC-related activities in support of cell bank preparation, cell culture production, vector production, cell therapy products, downstream processing, formulation, fill/finish, utilities, environmental monitoring, and building systems conducted in the biopharmaceutical manufacturing facility comply with clients’ needs and operates to provide customers with high quality biopharmaceuticals suitable for research, pre-clinical and clinical use. This position is responsible for all QC related activities and staff ensuring that these activities are conducted in a timely, efficient, and productive manner compliant with quality systems, contract and program requirements. These activities include the timely testing of clinical-grade biopharmaceuticals, the development, qualification/validation of new analytical methods for support of Process Development and Manufacturing and the translation of assay methods from clients and/or process development to the cGMP QC testing laboratory. The director will work closely with all departments, the project teams; and assist in project planning and time-line development. This individual will plan, implement, and coordinate the improvement of QC services considering the application of up-to-date technical, GMP and quality principles and preventing/correcting unsafe environmental and working conditions in the QC laboratories.
Execute all project, facility and FB related QC requirements for client-sponsored research, pre-clinical and clinical supplies ensuring that these activities are on time and on budget.
Develop, implement, maintain and revise QC methods, procedures and policies. Make decisions related to QC methods in regard to process, testing or specification changes or changes to equipment or facility systems in consultation with other FB staff.
Review data, as needed, generated by QC personnel conducting internal testing and review results from off-site testing. Write and/or review stability protocols, data and reports. Ensure that the QC laboratory facilities operates efficiently including reagent and raw materials sourcing and inventory, staff utilization, scheduling, off-site analytical testing, in-process/release/stability testing, equipment usage, archives, development of new assays, the internalization of outsourced/client testing and the purchase of needed analytical/monitoring equipment. Ensure that QC facilities meet cleaning, maintenance, calibration and validation requirements. Improve and make more time/cost efficient the existing QC activities and facilities. Assure that department activities are in compliance with quality systems and Current Good Manufacturing Practices (cGMP’s) regulations, calibration and validation and revalidation schedules, safety requirements and FB practices and policies. Attract and communicate with clients and assist in development of potential project proposals focusing on analytical testing aspects. Host client and internal QA audits of the QC laboratory and methods and prepare audit responses or delegate same. Oversee completion of all audit response actions on time. Participate in prospective and current client meetings and visits. Improve and make more time/cost efficient the existing QC facilities. Prepare yearly department budget and operate within same. Negotiate with off-site laboratories and material vendors to identify cost saving options.
Monday through Friday, 8am to 5pm.
Overtime is required to meet timelines including weekends, evenings, holidays.
Master’s degree in an appropriate area of specialization and two years of appropriate experience; or a bachelor’s degree in an appropriate area of specialization and four years of appropriate experience.
This is a time limited position.
A PhD with 10 years of laboratory experience in the biotechnology/pharmaceutical industry or scientifically related areas. A working knowledge of cGMPs, particularly related to QC.
Five years of supervisory experience. Experience with biopharmaceutical assay development. Knowledge of ICH , USP , and FDA requirements. Highly motivated, hard-working, multi-tasking. Must be able to speak, read, and write in English in order to analyze and review technical information and written reports and present information to internal staff, regulatory authorities and external clients/parties as necessary. Familiarity with technical literature databases, genome sequencing, word processing programs and spreadsheets is mandatory, as is a capacity to follow written procedures. Outstanding planning, organization, communication, leadership skills. Proficient in the use of personal computers and MS Office programs.
Prior experience preparing data summaries for IND and other regulatory submissions along with knowledge of current industry standards are strongly preferred.
Health Assessment Required:
Special instructions to applicants:
Open Until Filled:
University of Florida UFL - 13 months ago