Description
We are currently seeking a Manager to oversee the Manufacturing Department and associated facilities for production of the company's cell-based products for administration into human subjects. This position reports to the Sr. Director, Cell Processing. Responsibilities will include:* Plan and oversee all activities related to the GMP manufacture and distribution of cell products for use in clinical trials. This includes the isolation and purification of cell populations from primary tissue, their subsequent culture-expansion and cryopreservation to create cell banks; the onward production of final products for human administration. Such activities shall include supply chain management from tissue procurement to final product distribution
* Manage external contract relationships as they relate to supply chain management, product manufacturing and product distribution
* Develop and administer budgets, schedules and performance requirements for the GMP Manufacturing Department
* Compile and revise SOPs, Production Records, Master Validation Plans, Qualification and Validation protocols, reports and other documentation as required to ensure GMP and regulatory compliance
* Plan and oversee the execution of all activities related to the operation, maintenance, qualification and validation of company's GMP facilities, equipment, systems and utilities. Investigate discrepancies and out-of-specification results, recommend corrective actions necessary to assure conformity with regulatory requirements
* Liaise and co-ordinate with Technical Development and QA groups to facilitate the transfer and qualification of new processes and process improvements into GMP Operations
* Liaise and co-ordinate with Research, Technical Development, Quality Assurance, Quality Control, Regulatory and Clinical groups to facilitate efficient GMP operations to meet company objectives and clinical trial program demands
* Ensure staff are appropriately trained in process methods and associated requirements of operations under GMP, GTP and/or ICH compliance
* Ensure operations and activities are executed in accordance with all internal SOPs, procedures and policies and in accordance with all county, state, and federal regulations including GMP, GTP & ICH
* Review and analyze manufacturing, quality control, maintenance, and operational reports to determine process and facility performance metrics and identify areas for improvement of cost and efficiency
* Stay current with technical, regulatory and operational advances and trends in the field and apply such knowledge to ongoing operations
* Other duties as may be assigned Candidate must possess:
* BS, MT(ASCP), or equivalent qualification
* At least 7 years GMP manufacturing operations experience in the biotechnology industry at the manager level
* Demonstrated leadership and managerial responsibility
* Experience with, and an in-depth understanding of, primary mammalian and/or stem cell culture, closed system processing methods and their application from primary tissue processing to finished product is required
* Proven track record of success in leading and managing the execution of complex multi-faceted projects in a fast-paced operations environment
* Expert knowledge of GMP, GTP and ICH regulations and their application
* Strong work ethic and a proven ability to work well in a multi-disciplinary project team environment
* Solid understanding of cell process and cell culture techniques for primary cells and mammalian cell culture outside of the hybridoma field
* Knowledge of cGMP cell culture processes, equipment, closed systems, cryopreservation techniques, and cell based assays, immunoassays, FACS analysis, primary cell characterization, and relevant laboratory instrumentation
* Excellent organizational, written communication and oral communication skills.
To find out more about Real please visit www.realstaffing.com