Head: Biotechnology Product Development at National Bioproducts Institute

Minimum Requirements

• Masters degree in Biotechnology, Chemical Engineering or other relevant degree
• PhD in Biotechnology preferred
• Minimum of 3 years’ experience GMP or Biotechnology environment
• Minimum of 3 years’ experience at a management level
• Successfully track record in the field of Biotechnology R&D project management

Duties & Responsibilities

Grow and maintain NBI’s 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 NBI’s R&D objectives.
• Develop, grow and maintain NBI’s R&D capability and capacity in line with strategic and business directives.
• Deliver complex projects that combine objectives in new product development, influencing NBI’s 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 NBI’s Biotechnology Product Development
• Determines 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 products
• Researches, evaluates and responds to requests from customers for product development proposals
• Compiles 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 NBI’s product portfolio

• Provide technical and scientific input to identify appropriate medical device, diagnostic and therapeutic protein development projects in line with NBI’s 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 requirements
• Ensure 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 recipients

• Establish 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 development

• Identify 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 profiles
• Participate 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 NBI’s 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