The Manager, Downstream GMP Production Operations (Senior Biological Scientist) will ensure that the Center of Excellence for Regenerative Health Biotechnology ( CERHB ) biopharmaceutical contract manufacturing facility, Florida Biologix, provides its clients with the highest quality therapies for clinical and toxicological study use. The incumbent is responsible for downstream manufacturing operations including planning, coordination, data analyses and decision-making, adherence to cGMP standards, preparation, modification and/or review of all related downstream operational documents (SOPs, batch records, etc.), supervising, hiring and training unit personnel, and participating, hands-on, in production activities. The incumbent is responsible to maintain the GMP downstream purification suite, its equipment and support areas including the installation and qualification of new equipment when necessary. The incumbent will work closely with Process Development, other Manufacturing units, Quality Assurance, Quality Control, Facilities, Project Management and Marketing to complete all responsibilities. The incumbent ensures that downstream production operations are scientifically sound, efficient, successful, and operate within cGMP regulations, Florida Biologix SOPs and project specific budgets. In addition, the incumbent will participate in the optimization and scale-up of purification methods in Process Development and will work with the Downstream Scientific Research Manager to troubleshoot technical problems and in project planning and time-line development.
The incumbent is responsible for organizing, coordinating and supervising downstream manufacturing activities. Execute hands on and with staff all cGMP purification processes following production batch records including toxicology lots run in PD laboratories in accordance with production schedule. Supervise and train manufacturing operators and others including hiring and performance evaluation. Ensure correct and ample materials and supplies are available to meet the manufacturing schedule. Write, review and/or approve all executed production records including deviations and investigations. Investigate manufacturing issues and trouble-shoot to find solutions. Coordinate downstream manufacturing activities with other manufacturing units (buffer production and filling), Quality Assurance, Quality Control and Facilities Departments, to ensure on time project and run completion. Ensure that the Downstream Manufacturing Unit and its personnel operate in compliance with cGMP regulations. Stay current with regulations and guidance documents issued by US FDA and other regulatory authorities. Write, revise, and/or complete SOPs, raw material specifications, batch records and other relevant controlled documents required for the chromatography-based, filtration-based, and other separation-based processes and respective production equipment. Propose, carry-out and/or review appropriate calibration, qualification, preventive maintenance and changeover activities. 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. Assist the Scientific Research Manager in the development, optimization and scale-up of downstream purification processes in Process Development laboratory. Remain current with modern separation process technologies and science. Work with management team to develop proposals and pricing estimates for potential contracts and communicate with potential and existing clients.
Daily, Monday through Friday, 8:00 A.M. – 5:00 P.M. Evening, weekend and holiday work is required to meet production needs/schedules and project timelines and objectives.
A bachelor’s degree in an appropriate area of specialization and three years of appropriate experience. Appropriate college coursework may substitute at an equivalent rate for the required experience.
This is a time limited position.
Master’s or Ph.D. in biochemical engineering, biochemistry, molecular biology, or virology. In-depth practical experience in biopharmaceutical downstream processing (chromatography, filtration, centrifugation, etc.) and modern processing equipment use and maintenance (Quanti-sep, FPLC , TFF , etc.) including a minimum of 4 years work experience in this area. Applicants must have clean room experience and work experience in an FDA regulated cGMP environment. Supervisory experience is desirable.
Job Skills: Familiarity with word processing programs (MS Word), spreadsheets (MS Excel) and presentation software (MS Power Point) is mandatory. Excellent multi-tasking, organizational and oral and written communication skills including demonstrated technical writing.
Health Assessment Required:
Special instructions to applicants:
Post offer health assessment is required for occasional respirator usage and heavy lifting up to 50 lbs.
This position has been reposted. Previous applicants are still under consideration and need not reapply.