The Manager, Upstream GMP Production Operations (Coordinator 2, Research Programs/Services) will ensure that the Center of Excellence for Regenerative Health Biotechnology ( CERHB ) biopharmaceutical contract manufacturing facility, Florida Biologix, provides its cell culture-based production clients with the highest quality therapies for clinical use. This position is directly responsible for upstream manufacturing operations including technical and scientific planning, data analyses and decision-making, adherence to cGMP standards, development, modification and/or review of all related upstream operational documents (SOPs, batch records, etc.), attracting and servicing clients, hiring and training unit personnel, and participating, hands-on, in production activities as needed. This position is responsible for participating in designing appropriate facility and process changes and participates in the implementation of these changes including validations as they become necessary. This position serves as the supervisor for upstream manufacturing scientists and operators. This position will work closely with Process Development for process transfer, other Manufacturing Units, Quality Assurance, Quality Control, Facilities, Project Management and Marketing units to complete these responsibilities. This position ensures that technical production operations are scientifically sound, efficient, successful, and operate within cGMP regulations and Florida Biologix SOPs and each project’s budget. This person will be responsible for organizing, coordinating, managing and supervising the upstream manufacturing activities in flat stock, stirred tank and rocking bioreactors including production of adenovirus and adeno-associated virus in mammalian or insect cells to ensure production occurs on schedule and meets required timelines. Supervise and train manufacturing operators and others including hiring and performance evaluation. Perform inventory and ensure ample supplies are available to meet the manufacturing schedule. Perform upstream manufacturing operations, hands on, as needed, following approved written procedures. Write, revise, and/or complete SOPs, batch records and other relevant controlled documents required for mammalian cell-based and/or insect cell-based GMP production. Review and approve all executed production records including deviations. Investigate issues and trouble-shoot to find solutions. Write and/or review needed quality investigation reports. Ensure production facilities are maintained as required by SOPs and industry standards. Use industry accepted and modern processes and procedures. Meet project timelines.
The incumbent will ensure that the Upstream Manufacturing Unit and its personnel operates in compliance with cGMP. Stay current with regulations and guidance documents issued by FDA . Propose, implement and review appropriate calibration, validation, maintenance, and changeover documents and activities. Coordinate upstream manufacturing activities with other manufacturing units, Quality Assurance, Quality Control, and Facilities departments, to ensure on-time project completion. Improve (make more time efficient, cost effective, etc) existing unit operations. The incumbent must remain current with mammalian and insect cell culture, and upstream process technology and science. Work closely with Process Development to transfer new processes into the GMP environment including, Batch Record development, reagent sourcing and identifying and configuring new equipment and process rooms, as needed.
This person will attract and communicate with potential and existing clients. Work with management team to develop proposals and pricing estimates for potential contracts.
Other duties as assigned.
Typically, Monday through Friday, 8:00 A.M.to 5:00 P.M. Requires availability to work in the early mornings, evenings, weekends and overtime when required or needed by production schedule.
Master’s degree in an appropriate area of specialization; or a bachelor’s degree in an appropriate area of specialization and two years of appropriate experience.
This is a time limited position.
In-depth hands on experience in biopharmaceutical upstream cell culture processing (suspension culture, adherent culture, etc) and modern processing equipment use and maintenance (stirred tank bioreactors, Wave reactors, disposable systems, etc) including 10 years work experience in this area. Experience in mammalian and insect cell culture. Applicant must have clean room experience and must have work experience in FDA regulated cGMP environments. Supervisory experience is desired. Master’s degree in scientific field, e.g., molecular biology, microbiology, and/or cell biology is required.
Familiarity with word processing programs and spreadsheets is mandatory, as is a capacity to follow written procedures, and an ability to read, write, and understand English, particularly technical writing. Incumbent must have excellent organizational and oral and written communication skills. Working knowledge of modern laboratory procedures and microbiology techniques
Health Assessment Required:
Special instructions to applicants:
Post offer health assessment is required for Contact with Human Blood, occasional respirator usage and Human Pathogen Research (BSL2+/BSL3).