Leads and manages the Parenteral Lyophilization, Control Room & Pharmacy Areas (Lyophilizers preparation & operations, monitoring of GMP utilities/area conditions, dispensing/pre-weighing), while working closely with principal manufacturing centers (Parlyo, PSA, PVA) to produce high quality sterile products. Provides guidance to all manufacturing processes in order to meet production requirements. This position must comply with all Security guidelines, Environmental Health and Safety regulations, regulatory/compliance requirements, and the current Good Manufacturing Practices required by the job function. Ensures that personnel complies with the established curriculum to achieve proper knowledge transfer and personnel qualification such as, but not limited to aseptic techniques, isolation, lyophilization, sanitization, etc. Ensures the production scheduling by assuring the coordination of the manufacturing supervisors with the area planners and quality personnel, to organize and comply with daily production goals. Ensures that area equipment is well maintained, including but not limited to calibrations and preventive maintenances, in order to achieve optimal operational performance while maintaining regulatory and compliance requirements. Support a streamlined and continuous operation in key manufacturing centers (ParLyo, PSA, PVA) by ensuring a high service level. Provides leadership to the Manufacturing Alignment Team related to Lyophilization, Control Room and Pharmacy activities. Participates actively in the preparation of the department budget and effectively manages company funds and actives. Supports Productivity initiative programs by identifying efficiencies in the Operational areas, executing Process improvement and Lean initiatives and providing resources to support cross-functional productivity project teams. Supports all technology transfer activities, equipment qualification, process validation, troubleshooting clinical/experimental lots production, and process optimization by providing the necessary resources and process expertise. Coordinates maintenance windows for GMP utilities for all manufacturing areas, with Site Engineering/Facility Management teams, ensuring no impact to area schedules. Serve as the department point of contact for coordination of such activities. Serve as the department point of contact for routine maintenance shutdowns, representing all manufacturing areas. Responsible for ensuring availability of resources for execution of tasks during the shutdown, and timely startup of all areas. Support quality investigations related to lyophilization, GMP utilities and Pharmacy areas, and any other event related to support provided by areas under direct responsibility of the incumbent. Review and approve investigations as per site procedures. Provides support to the regulatory affair reports, customer complaints, and area exception reports (e.g., Quality Investigation Reports, Quality Complimentary Reports, Change Request Forms, etc.). Monitors, evaluates and communicates area performance metrics for safety, quality and productivity. Participates actively as a key contact for the Lyophilization, Control Room, Pharmacy/other support areas in internal and external audits. Improves current processes in order to optimize product efficiency/yields/cycle times/OEE. Supports the creation and revision of SOP's, WFP's special test protocols and related documents to assure compliance with cGMP's, Company policies/procedures and documentation practices. Maintains control of all environmental issues in Pharmacy area. Promotes and model the BMS Behaviors, facilitating teamwork, providing coaching and feedback etc. Supports all site Initiatives and any other assignments based on business needs. Serves as back up in the absence of the Site Director, Sterile Operations. BS Degree in Chemistry, Biology, Engineering, Pharmacy or related sciences. Eight (8) years of experience in Lyophilization technology in a sterile pharmaceutical manufacturing environment and five (5) of them in a supervisory position. Extensive knowledge and understanding of manufacturing processes associated with manufacturing of parenteral products in conventional aseptic and barrier isolation technology. Strong leadership skills while maintaining effective communication and interactions with superiors and colleagues. Team oriented with excellent interpersonal skills. Strong business sense; understanding of and capability to support both financial and quality objectives. Assertiveness and uncompromising attitude with regard to the quality standards applied in the day-to day activities. Ability to leverage both internal and external resources at various levels. Proficient in regulatory compliance requirements including but not limited to of GMPs, FDA, EMA, or other Global Health Authority regulations, EHS (OSHA). Strong interpersonal and teamwork skills; ability to develop and maintain effective professional relations with colleagues at all levels across the organization; ability to integrate actions toward objectives. Excellent and effective communication skills in both English and Spanish. Experience in writing technical reports and assessments, executive summary type presentations to senior management and technically detailed presentations to specialized technical groups such as Manufacturing Technology, Supply Chain, Engineering and QC/QA. Willing to work irregular hours, rotating shifts, weekends and holidays. SDL2017
Ciudad: manati
