Job purpose

· The Senior Technical Lead is responsible for providing technical leadership across process design, equipment qualification, production readiness, and commercialization activities.

· The role ensures that manufacturing processes are scientifically sound, operationally robust, compliant with GMP requirements, and ready for successful transfer into routine commercial production.

· The incumbent will support the development, implementation, qualification, and continuous improvement of manufacturing processes and associated equipment, working closely with Production, Engineering, Quality, Validation, Supply Chain, and Project teams to ensure readiness for new product introduction, process scale-up, technical transfer, and commercial launch.

· Ensures compliance in accordance with the Medicines and Related Substances Act 101 of 1965 and the Pharmacy Act 53 of 1974, and the organization’s policies, procedures, and other applicable laws.

Minimum qualification(s)

• BSc degree in Engineering, Science, Biotechnology, Pharmaceutical Sciences, or a related technical discipline.

• A postgraduate qualification in Engineering, Science, Pharmaceutical Manufacturing, Biotechnology, or Business Management would be advantageous.

Experience & industry knowledge

• 5-10 years Relevant experience in pharmaceutical, biotechnology, vaccine, or sterile manufacturing environments with 2-3 years management level experience.

• Experience in process design, process development, technical transfer, equipment qualification, production readiness, or commercial manufacturing support.

• 5-10 years Direct experience in GMP-regulated manufacturing environments.

• Experience supporting new product introduction, process scale-up, process validation, or commercialization activities would be advantageous.

Key Duties & Responsibilities

People Management

· Align departmental focus areas and outputs to the business’s objectives

· Conduct business, cross functional and departmental planning and execute activities within own scope of accountability.

· Adequate capacity planning and performance delivery in line with strategic, tactical and operational plans

· Role profiling, goal setting and performance management of managers and staff within the department.

· Develop and implement a knowledge management infrastructure within the department to ensure Intellectual Property is effectively maintained

· Growth, succession & retention of departmental talent.

· Accountability for own and team's personal and professional learning & development to ensure technical and leadership bench strength within the department

· Ensure accurate delegation of ongoing operational activities in the event of key staff members’ absence.

· Conduct effective employee relations in accordance with labour legislation, company policies and procedures and address any performance and conduct concerns and risks timeously.

Technical Competencies required to perform this aspect of the role:

· Relationship building ability

· Coaching/ mentoring ability

· Delegation and role clarity for team

· Negotiation Ability

Business and Operational Performance

• Translate site objectives into production priorities, campaign plans, daily targets and departmental KPIs.

• Monitor plan attainment, schedule adherence, throughput, right-first-time performance, deviations, yield, labour utilisation and downtime.

• Support budgeting, forecasting and cost control for labour, overtime, consumables, gowning, utilities, training and production-related expenses.

• Lead or support technology transfers, process changes, validation activities, operational readiness and continuous improvement projects.

Technical Competencies required to perform this aspect of the role:

• Ability to understand, develop and commercialize aseptic processes for the manufacture of drug substance and fully finished drug product.

• Lead end-to-end Drug Substance operations including inoculation, cultivation, harvesting, inactivation, dispensing, buffer preparation, purification and formulation.

• Ensure batch readiness, material availability, equipment readiness, shift handovers and execution against approved batch records, SOPs and validated processes.

• Maintain control of BSL-2 activities, including biological material handling, containment, decontamination, waste handling, access control and emergency response.

• Supplier engagement during design, FAT, installation and qualification activities.

• Ability to forecast future resource requirements with future commercial demand.

If you do not receive a response from us within three weeks of submitting your application, please understand that your application was not successful.

We believe in the magic of diversity within teams and to achieve this, we do apply Employment Equity principles during our selection process where this is necessary to achieve such diversity.

Disclaimer:

Dear Applicant, we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application.