R&D Director
- جدة
- دائم
- دوام كامل
- Participation in selection of the new products to be developed by R&D, Scheduling time plans for the projects that are in hand and follow-up to complete them in the scheduled time.
- Guiding the team for choosing the most suitable composition and process during development of the products from trial stage to product scale-up stage.
- Approving the R&D manufacturing records for stability and bio batches.
- Coordinating with Engineering Department in designing the primary and secondary packaging material for the developed products.
- Guiding the analytical method development section for the development and validation of the test methods for the newly developed products and Approving all documents of analytical method development section.
- Ensure the teamwork among the different sections of R&D department by defining the responsibilities of each section and emphasizing the priorities for the projects in hand.
- Supporting all R&D employees by arranging internal and external trainings in order to develop their professional skills and to improve their overall performance.
- Participation in solving troubleshooting and market complaints.
- Design and approval of protocols and reports of bioequivalence reports.
- Representing the R&D in all JP management meetings and implementing the company's management policies.
- Participation in the planning / marketing meetings for launching the new products by providing the required documents, drawings and technical support.
- Replying answers to the technical queries of SFDA Saudi Arabia and other export countries for the registration of new products.
- Prepare and propose annual budgets for Capital Expenditure, Operating Expenditure, and Human Resources.
- To control the operating expenses within approved annual budget.
- To ensure procurement of capitalized items through negotiations on price, features and as per the user requirements specifications with the suppliers and manufacturers.
- To review and sign on behalf of the company as authorized signatory on contracts, confidentiality agreements, technical agreements, applications for marketing authorizations, renewals of marketing authorizations.
- To approve purchase requisitions & notifications.
- Approval of leave applications, advance salary requests.
- To approve new employee requests, induction and orientation records.
- To approve training records and documentation.
- To perform all review and approval transactions in SAP system for all activities of R&D.
- Authorized to issue explanatory note /warning letter/ disciplinary action, to be taken if in case of subordinate's inappropriate behaviour / insubordination/ performance is not in the interest of the organization.
- Responsible for goal setting, development plans and performance review of all personnel in the department.
- Provide clear direction, prioritize tasks, assign and delegate responsibility and monitor the workflow.
- Review and approve individual performance and provide regular feedback, development opportunities and coaching, taking prompt action, where necessary.
- Provide and ensure ongoing training for all the departmental staff as required by operational demands. Ensure all training within the department is tracked according to the current SOPs. Evaluate and address employee performance through established HR systems. Establish and monitor performance metrics, Conduct annual performance evaluations for direct reports, Enhance the overall effectiveness of the team.
- Ensure departmental compliance with Company's policies, processes, practices and systems, and maintains Company's high standard of work and work ethic.
- To interview and select prospective candidates for appointment and maintain staff records.
- Authorized to develop and control work practices, functions of all managers and supervisors working in the department.
- Responsible to delegate the authority to subordinate.
- Prepare & participate in formulation of policies and ensure implementation of safety, health and industrial hygiene, quality, work ethics related policies, procedures and practices.
- Masters Degree in Pharmacy, Ph.D. is preferred. Minimum of 15 years in regulated market formulation development.
- Degree in Business Management Studies is preferred.
- Minimum 20 years of experience in research and development functions and in particular formulation development of some of the Galenic forms : Sterile preparation like ophthalmic solutions, suspension, injections & well acquainted with BFS technology. Solid Oral dosage forms: Soft gelatin capsules, Hard gelatin capsules, IR tablets, multilayer tablets, inlay tablets, chewable tablets, Mouth melts, pellets compressed into tablets, pellet manufacturing technology, modified release formulation, dry syrups Oral liquids, Topical Formulations.
- Hands on work experience of formulation development with proven track record.
- Publications in International Journals of high reputation.
- Knowledge of Clinical and Non clinical studies.
- Hands on work experience with Formulation Development as per Quality by Design is preferred.
- Knowledge of DMF, CTD and cGMP/GLP is a must.
- Knowledge of manufacturing instruments and equipment, utilities and facility is required.
- Knowledge of SAP or other ERP and Data management systems.
- Knowledge of patents, intellectual property rights, drug laws and regulations.
- Detailed knowledge of EU / US FDA / GCC / SFDA / ICH regulations and guidelines on drug development and submissions both pre and post approval guidelines.
- Experience working with CROs and/or contractors.