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Associate Director Process Improvement

Associate Director Process Improvement
Empresa:

Bristol Myers Squibb


Lugar:

Manatí

Detalles de la oferta

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. Summary: Lead the Sterile and Non-Sterile Operations Process Support team supporting (Sterile Manufacturing, Inspection Operations and Technology, Packaging Operations, and Oral Solid Dosage Operation) by providing leadership and direction for the projects implementation of sterile growth products (isolation technology, formulation, filling, serialization, automated inspection, automated assembly and packaging, new product launches, and/or any other strategic initiative). Provides guidance to the Operations processes in order to meet production, quality and safety 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 Responsibilities: 1. Partner with Engineering and Manufacturing Science & Technology teams to ensure new technologies are robust, address the needs of production, and take into account human factors and minimal downtime.2. Initiate and drive CAPAs/Change Controls as they relate to process changes, and/or improvements. Present to Change Control Review Board and leverage cross-functional resources for phase gate approvals. 3. Leverage lean tools, such as value stream mapping and Gemba walks, to identify bottlenecks and implement solutions to streamline production. 4. Design innovative solutions to improve operational safety, quality, efficiency, delivery, and costs. 5. Coordinate with Systems Engineering and Quality to ensure the seamless transfer of new products and processes into production, including all required SOP's and training records.6. Participate in the site audit program, ensuring compliance to all published procedures. Serve as Subject Matter Expert (SME) for all Production related equipment and systems. 7. Support investigation of non-conformances as they relate to the Production equipment, process, or systems. Facilitate cross-functional root cause investigation, author investigation summary, implement CAPAs, and effectiveness checks. 8. Work with engineering and equipment vendors to design, procure, install, and validate new in-process and/or control systems.9. Provide solutions for process control strategies, analytical data tools, and data/system models and implement into production processes10. Participates actively as a process support contact for operations in internal and external audits. 11. Improves current processes in order to optimize product efficiency/yields. 12. Supports the creation and revision of SOP's, WPP's special test protocols and related documents to assure compliance with cGMP's, Company policies / procedures and documentation practices.13. Promotes and models the BMS Core Behaviors, facilitating teamwork, providing coaching, feedback etc.14. Performs as back up in the absence of the Site Directors for Sterile and Non Sterile Drug Product Operations as needed.15. Ensures Process Support personnel complies with the established curriculum to achieve proper knowledge transfer and personnel qualification.16. Participates actively in the preparation of the department budget and effectively manages company funds and actives. 17. Ensures a streamlined and continuous operation between Sterile and Non Sterile Operations.18. Supports Productivity initiative programs by identifying efficiencies in the Operational areas and providing resources to support Productivity teams. Knowledge/Skill: BS Degree in Chemistry, Biology, Engineering, Pharmacy or related sciences. Ten (10) years of experience in combined experience on formulation, filling, inspection and packaging processes including liquid and lyophilized vials and pre filled syringes within pharmaceutical environment and five (5) years of them in a managerial position. Experience in new product launch activities related to packaging, including combination products (medical devices). Extensive experience (more than five years) managing Parenteral products inspection, including isolation technologies, development of inspection methodologies for actual and new products. Knowledge in oral solid dosage processes. Possess excellent organizational skills and the ability to successfully manage multiple technical projects and priorities. Knowledge in Engineering principles. Ability to work in a fast paced, complex and changing environment. Ability to lead technical changes as it applies to resources and budget allocation. Strong knowledge and practical experience in manufacturing processes, technologies and processing equipment, CGMP's and FDA regulations and trends. Strong project management skills and experiences. Excellent analytical and strategic thinking skills and experiences. Lead management, interpersonal and teamwork skills, strong mentor, with excellent people development skills and track record of achievement in this direction. Outstanding communication skills, both in English and Spanish (oral, written). Outstanding leadership skills and ability to lead Process Improvement goals and objectives and influence the site management team to attain sustained excellence standards. Outstanding decision making skills and risk taking. Experience in writing technical reports and T&E's, 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. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Data Privacy Link We're creating innovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.


Fuente: Adzuna_Ppc

Requisitos

Associate Director Process Improvement
Empresa:

Bristol Myers Squibb


Lugar:

Manatí

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