R&D Manager CANTANHEDE - PORTUGAL Tilray is a global leader in medical cannabis research and production dedicated to providing safe, consistent and reliable therapy to patients.
We are the only GMP certified medical cannabis producer currently supplying products to thousands of patients, physicians, pharmacies, hospitals, governments and researchers in Australia, Canada, the European Union and the Americas.
Our team of PhD scientists, botanists and master horticulturists are leaders in cannabis research and related agricultural sciences.
We strive to improve scientific understanding of the potential applications of medical cannabis and have invested in developing continuing medical education programs for health care practitioners around the globe.
Looking to develop your career at the forefront of a rapidly expanding industry?
Ready to apply your talents to make a positive difference in the lives of patients around the globe? Please apply in English Reporting to the Director of R&D, the R&D Manager is responsible for leading product and / or process development, and continuous improvement projects to support new product launches and existing manufacturing operations including process engineering technical skills to increase the knowledge to offer the best and state of the art technologies used in the industry to Operations team in Cantanhede, Portugal.
The R&D Manager is accountable for R&D structure and initiatives in site-level, working in a cross functional structure closely with Operations, Quality, PMO, Regulatory and other R&D areas to ensure new products are registered and launched to markets successfully;
and achievement of the KPI targets on COGS, gains of productivity, efficiency and costs reduction as well as in compliance with the cGMP and Health, Safety & Environment (HSE) guidelines established by Operations Management.
Role and Responsibilities
Prepare and manage R&D budget in site-level;
Prepare CapEx projects with focus on herbal extraction, refining and isolation of cannabinoids-based actives providing scope, budget estimate and scheduling to throw Stage Gate Process evaluation for approval of new investments in manufacturing processes;
Communicate and manage expectations of the several stakeholders along whole Tilray s management chain in site-level of the R&D s investigational reports and actuation of new investments for manufacturing processes;
Lead the design and development of new equipment technologies, including liaising with external vendors and / or consultants for new equipment projects;
Plan, design and execute R&D activities for product development to run safely and effectively from a lab scale / pilot plant to scale up of new manufacturing processes in accordance with best known practices ensuring cGMP compliance with collaboration of operational areas;
Manage R&D CapEX projects in site-level considering all project phases (Initiation / Planning / Execution / Monitoring & Controlling / Conclusion) according to PMI good practices for new manufacturing processes;
Contribute to the Process Hazard Analysis (PHA) of all new processes under R&D responsibility assuring that all identified hazards are addressed prior to performing any activities within Operations;
Prepare Standard Operational Procedures (SOP) for new manufacturing processes under R&D responsibility, training operations personnel on the use of the systems and procedures to handover to Operations;
Support Manufacturing to prepare Master Batch Records (MBR) in accordance with GMP related documentation;
Prepare and submit for approval Bill of Materials for new products;
Work closely with Operations and Quality for continuous improvement, and / or cost improvement, and / or process optimization, and / or increasing efficiency for herbal extraction, refining and isolation of cannabinoids-based actives processes;
Prepare and execute Technology Transfer packages for processes / products from Tilray Canada to Tilray Portugal;
Work with the PMO, Regulatory, Quality & Compliance teams to provide required analytical data or other required information of API, intermediates, raw materials and excipients, and packaging materials as demanded for submission of dossiers to Official Authorities;
Communicate to Global R&D team development of technical solutions and good practices, and business trends opportunities and competitive information from EU market to contribute to Tilray s strategy planning;
Provide to General Manager and Chief Science Officer investigational or summary reports on to make decision as needed basis.
Qualifications and education requirements
Master’s degree in chemistry, chemical engineering, pharmaceutical science, biochemistry, or similar technical field. PhD degree would be an asset;
5+ years in a relevant technical development, R&D, or related engineering or development role. Experience in pharmaceutical setting would be an asset;
Proven experience and track record of success in large scale pharmaceutical, health product, food, or cosmetics manufacturing environment;
Experience with scale up of novel chemical methods from lab to pilot scale;
Strong working knowledge of cGMP practices, Standard Operating Procedures (SOP), and Master Batch Records (MBR);
Must have the proven ability to organize and prioritize work for efficient operations;
Results driven and able to deal with multiple projects / tasks;
Must be able to work cross-functionally and communicate properly throw all operational levels;
Leadership ability and teamwork capacity;
Substantial attention to detail is required (analytically minded);
Strong computer skills in a Windows environment excellent Excel skills.