Open Positions 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

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Minimum Requirements

• Masters degree in chemistry, analytical chemistry, biochemistry or other relevant degree
• PhD in Chemistry preferred
• Computer literacy: MS Office, SAP, LIMS
• At least 5 years laboratory experience
• At least 3 years QC lab management experience in a pharmaceutical or similar environment
• Complete understanding of cGMP, GLP and international pharmaceutical standards
• Hands on experience with internal and vendor audits will be an advantage

Duties & Responsibilities

QC department / laboratory management

• Plan and coordinate sample testing based on product specifications and production needs.
• Manage QC lab staff for timely analysis and reporting of raw materials and products.
• Report results in various formats, including certificates of analysis (CoAs).
• Ensure prompt release of raw materials and intermediate products for production.
• Develop and enhance internal quality control systems in line with GMP and industry standards.
• Implement and maintain an external proficiency testing program.
• Establish quality requirements and maintain in-house controls and reference standards.
• Review and approve QC activities and procedures for quality and compliance.
• Stay updated on cGMP requirements and regulatory expectations.
• Regularly review QC procedures to ensure best practices.
• Ensure adherence to scientific principles and proper statistical methods in QC analysis.

Specifications for all materials

• Approve, develop and maintain specifications for all materials used in pharmaceutical and diagnostic product production.

SAP and LIMS

• Ensure all SAP and LIMS transactions are completed as required for the release of raw materials, intermediates and final products.
• Perform SAP tasks as required by the quality management system and other business processes.
• Ensure LIMS and SAP is optimally set up and utilised to support effective, productive and efficient QC laboratory operations, and identify opportunities for further improvement to maximise LIMS functionality.

Analytical methods and QC equipment

• Assess the feasibility and benefits of new analytical methods, preparing justifications and CAPEX requests.
• Develop user requirement specifications for new QC facilities, equipment, and contract testing.
• Assist the Validation Team in preparing IQ, OQ, and PQ documents for qualification.
• Coordinate equipment qualifications and method validations, providing necessary documents to Regulatory Affairs for SAHPRA submissions.
• Oversee the implementation of new analytical methods and QC equipment post-SAHPRA approval, following NBI’s change management procedures.
• Maintain a program for calibrating, servicing, and maintaining analytical equipment to ensure accuracy and prevent breakdowns.

Management of external / contract laboratories

• Identify and assess external laboratories for analytical testing as backup to in-house QC.
• Ensure contract laboratories use suitable and validated analytical methods.
• Audit contract laboratories per as NBI’s vendor management program.
• Review external testing service agreements

Company strategy

• Contribute to company strategic plans and their implementation.
• Participate in strategic initiatives and continuity in leadership.
• Ensure alignment of the QC department with company-wide strategic initiatives.

Review and reporting of trends

• Monitor, analyse and report on trends of key QC performance indicators as part of monthly, quarterly and annual reviews and reports, including annual product quality reviews, or APQRs.
• Coordinate with applicable QC staff to ensure the monthly review of reference standards and inhouse controls is performed, including statistical analysis and reporting of the trends.
• Ensure the appropriate use of sound statistical analysis of QC results.
• Prepare quarterly and annual reports on analytical results of raw materials, in-process and final product testing, as well as utilities.
• Attend quarterly and annual review meetings and provide input into the meetings as required.
• Coordinate with the Lead QC Analyst to ensure that stability reports are prepared, reviewed and shared with stakeholders.

Health, safety and the environment

• Ensure compliance to all relevant legislation e.g. Occupational Health and Safety Act.
• Coordinate the investigation of SHE incidents in the department, and identify and implement effective CAPA’s to prevent recurrence.
• Ensure that NBI’s procedure on waste management is being followed in the laboratory.

Support for other NBI departments

• Stay updated on advancements in analytical techniques for biopharmaceuticals to support interdepartmental discussions.
• Contribute to cross-departmental projects and troubleshooting with QC support and technical advice.
• Evaluate new raw materials, excipients, printed packaging materials, and closure systems for production support.
• Provide analytical support for new product development

Maintain the quality system to ensure GMP compliance

• Ensure compliance to NBI’s quality management system, GMP principles and SAHPRA guidelines in the QC department.
• Establish, review, and enforce SOPs for processes and analytical methods.
• Communicate QMS requirements to staff.
• Prepare for and participate in GMP audits by third parties and regulatory authorities.
• Conduct internal audits and implement corrective actions for continual improvement.
• Coordinate with QC staff to identify, document and implement CAPAs for non-conformances from audits and inspections.
• Collaborate with Quality Division managers to foster a culture of quality and uphold the NBI Quality Policy.
• Identify and implement continuous improvement initiatives, including annual Quality Objectives for the QC department and monitor progress.
• Coordinate out-of-specification root cause investigations per NBI’s SOP and distribute reports to stakeholders.
• Coordinate customer complaint investigations, and prepare reports in compliance with NBI’s SOP.