Job Description

Head: Biotechnology Product Development - PinetownFull job descriptionJob Advert SummaryGuided by its purpose to provide products for patients to alleviate pain and suffering and improve their quality of life, NBIs vision is to be the leading African manufacturer and supplier of quality therapeutic proteins and diagnostic products.National Bioproducts Institute NPC has a vacancy for the role of Head: Biotechnology Product Development. The successful incumbent will be required to;Develop and grow NBIs R&D capabilities in line with strategic directives and expand NBIs diagnostic and therapeutic product portfolio;Manage and grow NBIs Biotechnology Product Development department by providing the required resources and support for the optimal functioning of the Department;Identify appropriate medical device, diagnostic and therapeutic protein development projects in line with NBIs strategic and business objectives, in consultation with relevant stakeholders;Manage, support, facilitate and co-ordinate and apply project management approaches to the development activities to ensure successful completion;Facilitate the internal technology transfer of the developed processes and products to Operations and Quality Control;Advise internal stakeholders on strategic biotechnological topics based on the latest scientific developments, trends and discoveries.Applications are invited from suitably qualified and experienced candidates.Minimum RequirementsMasters degree in Biotechnology, Chemical Engineering or other relevant degreePhD in Biotechnology preferredMinimum of 3 years experience GMP or Biotechnology environmentMinimum of 3 years experience at a management levelSuccessfully track record in the field of Biotechnology R&D project managementDuties and ResponsibilitiesGrow and maintain NBIs therapeutic protein and diagnostic development capabilities in line with strategic and business objectives. Ensure that the financial accounting of NBI complies with IFRS;In collaboration with the Head of QMSA:Build, equip, implement and maintain a well-resourced product development suite/laboratory to fulfil NBIs R&D objectives.Develop, grow and maintain NBIs R&D capability and capacity in line with strategic and business directives.Deliver complex projects that combine objectives in new product development, influencing NBIs strategic growth, operational and commercial outcomes.Provide resources for the effective functioning of the Biotechnology Product Development Department.Accountable for directing scientific and technical development within the Department.Create awareness of intellectual property and licensing issues and enable a broad understanding of technologies including emerging technologies to NBI staff.Review scientific literature, abstracts, patents, and applicable method papers as appropriate.Conducts literature research and prepare technical reports relating to identified research priorities.Provide high level report back on the functioning of NBIs Biotechnology Product DevelopmentDetermines research needs through consultative collaboration with internal and external stakeholders.Collaborates with other functions/departments within NBI to improve existing pharmaceutical products and create new products.Ensures ongoing up to date knowledge of cutting edge technologies in the Biotechnology field as it related to diagnostics and biologics/biosimilars through extensive reading, research and maintaining and developing contacts with experts in the field.Co-ordinates research and development of processes leading to the reproducible, practical and economical production of antibodies and pharmaceutical productsResearches, evaluates and responds to requests from customers for product development proposalsCompiles and submits proposals and business plans to external stakeholders for funding.Maintains relationships with key external stakeholders and funding organisations such as the relevant government departments, local and international research institutions, WHO, academic institutions, etc.Identify suitable R&D projects, and provide resources to manage and report on the R&D projects to expand NBIs product portfolioProvide technical and scientific input to identify appropriate medical device, diagnostic and therapeutic protein development projects in line with NBIs strategic and business objectives, in consultation with relevant stakeholders;Inculcate a project management approach to ensure that projects are adequately defined and managed in terms of milestones, timelines, budgets and resource requirementsEnsure that development projects are successfully completed on time and within budget.Effectively oversee and support diagnostic and therapeutic protein development activities through application of scientific and technical knowledge.Implement and use an appropriate performance monitoring/ measuring tool for project timelines.Ensure that projects are completed in such a way that is feasible, practical, scalable, economical, in line with cGMP and other requirements.Enable staff to work efficiently through regular project team meetings to monitor progress against milestones, budgets and risk mitigation plans and resolve technical quality or resource issues smoothly.Develop and implement improved, cost-effective manufacturing conditions for scale-up of products/processes from pilot to commercial scale, in line with operational, quality, GMP and other requirements.In collaboration with the Procurement and QC Managers, identify and evaluate potential external service providers who possess the quality requirements, technical capabilities and cos-effectiveness.Provide project updates through presentations and reports to NBI management.Identify and use and adhere to project planning features of the design control requirements of ISO13485:2016 to adhere to product development requirements though the development life cycle, culminating in product registration.Technology transfer of completed products and processes to internal recipientsEstablish framework of business processes and tools to ensure the successful internal transfer of completed products to internal recipients within defined timelines.Oversee the preparation of detailed product development reports, standard operating procedures, specifications and other information that is required for the successful transfer of the product and further clinical and non-clinical development.Coordinate and oversee the pilot scale manufacturing of the developed products by working directly with the relevant internal stakeholders such as production managers and section heads.Participate in team meetings on new product or process recommendations and help evaluate their impact on the routine production.Provide input into market and business analysis in support of the Head of Business Development.Provide technical advisory and problem solving services to the internal recipients relating to the developed products and processes.Maintain the quality system to support successful product developmentIdentify and ensure application of and adherence to relevant quality management system requirements from conception stages throughout the life cycle of acquired product development to ensure final product registration.Ensure applicable quality systems and regulations are communicated and staff are trained in them.Prioritize and implement principles and guidelines of GMP, ISO 14971, 13485 and related standards in the research and developmental profilesParticipate in hosting of QMS auditing activities by third parties and regulatory authorities.Use project-appropriate QMS guidelines to guide and evaluate performance and monitor progress of projects in line with the NBIs vision and strategy.Ensure QMS guidelines are used during transfer of new products or process improvement to production or routine operation.Manage risks by applying risk standards throughout the lifecycle of the developed product or process.Evaluate and ensure that QMS is applied for those projects that are outsourced or have external operations.Support regulatory submissions by assisting with preparation of regulatory documentation.Ensure that quality agreements are in place for service providers

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