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Job #03328

About our client Our client is a leading tissue therapy and development company headquartered in Florida. They are entering a significant growth phase and have strong funding from major government agencies. With an experienced management team and empowering corporate culture, this is a great opportunity for an entrepreneurial candidate that wants to put their drive and initiative to work! Position Location Production and Operations Manager Florida Salary Highly competitive package, commensurate with experience Responsibilities 1) Handle GMP Production and Operations including Operations (facilities, equipment, GMP purchasing) and Production (procurement, production, inventory planning, QC, environmental monitoring, etc.) 2) Manage and oversee procurement services provided by contracted procurement agents such as Placenta Procurement Program with regards to placenta inventory 3) Provide monthly metrics to EVP to monitor procurement activity 4) Handle and oversee processing operations including routine manufacturing, custom product manufacturing, QC, environmental monitoring and process improvements 5) Manage and communicate with the GMP Manufacturing Supervisor and provide direction for daily activities including problem-solving and mentoring 6) Oversee planning and prioritizing workday schedule, organizing, communicating with and motivating employees 7) Manage finished product inventory to ensure adequate levels are maintained based on usage projections provided by the EVP 8) Apply the key requirements of GTP, donor eligibility and FDA requirements to the products that the company manufactures 9) Manage and oversee clean room monitoring to maintain a controlled environment as required under GTP/GMP/ISO 10) Perform functions necessary for effective management of the Production Department including provision for the selection and development of employees, budget administration, employee safety, employee counseling and motivation 11) Liaise with other department managers to resolve issues and problems concerning Production 12) Oversee the critical aspects of processing and equipment with regard to product and process quality/efficiency 13) Develop and implement process improvement procedures for the production area 14) Review and update SOPs as needed 15) Oversee the performance of SOP verification as related to production processes 16) Optimize current processes to increase efficiency, improve quality and reduce costs 17) Ensure that the supervisory review of all records such as calibration, environmental monitoring and batch records are performed as prescribed 18) Serve as a member of the Internal Audit Team to perform selected audits in areas outside of production or operations 19) Ensure that all quality control is performed on all processes, processing equipment and systems within the Production Department 20) Conduct Level III training of staff in the division on technical procedures 21) Develop/present metrics to EVP Technical and Regulatory Affairs to identify performance/trends within the Production Department 22) Work with the EVP, Technical and Regulatory Affairs to determine and execute inventory planning, production efficiency, production planning, cost reduction and provide assistance with budget preparation 23) Manage coordination of building and facility operations (construction, renovations, clean rooms, etc.) 24) Handle raw materials procurement and management 25) Manage GMP purchasing operations and activities 26) Handle the writing, implementation and performance of procedures for qualification as well as validation of equipment/processes 27) Manage and oversee equipment validations including Installation Qualification (IQ), Operational Qualifications (OQ) and Performance Qualification (OQ) as well as oversee equipment problem resolution 28) Review and write SOPs for GMP Facility/Purchasing/Equipment/Operations 29) Manage and communicate with the Operations Supervisor when the determination is made of the need for contracts with vendors, manufacturers, suppliers, service contractors and procurement agents 30) Ensure that contracts are written and approved by the appropriate personnel 31) Manage and optimize the computer data software systems as it relates to technical division usage 32) Oversee the testing of device/products for function and documentation of results 33) Provide feedback to the Design Team on the results of the design and development effort 34) Perform designing and product development/testing for other products in the product pipeline and perform design transfer to manufacturing 35) Perform other duties and oversee other projects as assigned Requirements 1) Bachelor’s degree in Biology, Laboratory Sciences or a related field/equivalent experience 2) 2+ years of managerial experience working in a GMP environment in a biotech, biologic or pharmaceutical organization 3) Experience in handling laboratory equipment and working in an aseptic environment 4) Experience in writing and executing procedures 5) Excellent communication skills (written and oral) 6) Superb time management, IT (MS Word, Excel, Access, Database, ERP systems) and decision-making skills 7) Ability to exercise sound judgment and apply theoretical knowledge to the practical aspects of cell and tissue manufacturing