Production Supervisor: Drug Substance

Job Purpose

• Supervise safe, compliant and efficient Drug Substance manufacturing activities across upstream and downstream operations.
• Ensure production is executed in accordance with approved batch records, SOPs, cGMP, BSL-2 biosafety requirements and the production plan.
• Lead production teams on shift or as allocated, maintain inspection readiness and escalate delays, risks or quality concerns timeously to the Drug Substance Manager.

Minimum Qualifications

Required:

• Relevant tertiary qualification in Biotechnology, Medical Bioscience, Microbiology, Life Sciences, Engineering, Pharmaceutical Sciences or an equivalent science / manufacturing discipline.
• Degree or diploma in Biotechnology, Life Sciences, Engineering, Operations Management or Production Management.
• Formal training in biosafety, deviation investigation, root cause analysis, contamination control or GMP supervisory practices.

Experience & Industry Knowledge

Required:

• Experience in Drug Substance manufacturing within a GMP-regulated pharmaceutical, vaccine, biological or biopharmaceutical environment
• Demonstrated competence in cGMP, cleanroom behaviour, documentation practices and BSL-2 biosafety controls.
• Working knowledge of Drug Substance operations, including upstream activities such as inoculation, cultivation, harvesting, inactivation and decontamination.
• Working knowledge of downstream or support activities such as dispensing, media preparation, media heat sterilisation and tangential flow filtration purification.

Preferred:

• Supervisory, shift lead or senior technician experience in a GMP manufacturing environment.

Experience managing teams, production schedules, batch documentation, deviations, CAPAs, change controls and audit readiness activities.

Key Duties & Responsibilities

People Management

• Supervise Senior Production Technicians, Production Technicians and Production Assistants to ensure safe, compliant and right-first-time execution of work.
• Allocate daily work, confirm role clarity, monitor attendance and ensure adequate shift coverage, skills mix and handover between teams.
• Coach team members, support training completion and address performance, conduct or capability concerns timeously in line with company procedures.
• Promote a culture of safety, quality, accountability, teamwork, good documentation practice and continuous improvement.

Technical Competencies required to perform this aspect of the role:

• Staff supervision and coaching
• Shift planning and resource allocation
• GMP training and competency management

Business and Operational Management

• Prepare, coordinate and communicate the production plan for the DS Suite in alignment with site priorities, campaign requirements and available resources.
• Monitor daily plan attainment, schedule adherence, material readiness, equipment readiness, documentation readiness and labour utilisation.
• Escalate delays, constraints, deviations, safety concerns or quality risks to the Drug Substance Manager timeously with proposed recovery actions where possible.
• Work cross-functionally with pharmacists, pharmaceutical assistants, QA, QC, Engineering and Technical Transfer to support batch execution, investigations, process changes and operational readiness.

Technical Competencies required to perform this aspect of the role:

• Production planning and schedule control
• KPI monitoring and escalation management
• Cross-functional coordination and technical communication

Manufacturing and Technical Delivery

• Supervise upstream BSL-2 activities including inoculation, cultivation, harvesting, inactivation and decontamination in accordance with approved procedures and biosafety controls.
• Supervise downstream and support activities including dispensing, media preparation, media heat sterilisation and purification by tangential flow filtration.
• Ensure batch readiness by confirming materials, equipment, rooms, documentation, trained personnel and cleaning status before execution.
• Monitor process execution, critical steps, in-process controls, abnormal trends and operational issues, and escalate matters that may affect safety, quality, compliance or supply.
• Ensure accurate and timely completion or review of batch records, logbooks, cleaning records and electronic records in line with data integrity expectations.
• Support SOP, work instruction and batch record updates to ensure documents remain current, practical and aligned with validated processes.

Quality, Safety, Biosafety and Audit Readiness

• Ensure the DS Suite remains audit ready by maintaining current procedures, complete records, controlled housekeeping, compliant behaviours and readiness for internal or external inspection.
• Ensure manufacturing activities comply with cGMP, approved SOPs, batch records, validated processes, contamination control expectations and BSL-2 biosafety requirements.
• Initiate or support deviations, CAPAs, change controls, audit responses, root cause analysis and risk assessments for events within the supervisor’s area of responsibility.
• Promote safe biological material handling, containment, decontamination, waste handling, access control and emergency response practices.
• Escalate risks that may impact product quality, patient safety, personnel safety, biosafety, regulatory compliance or production continuity.

Technical Competencies required to perform this aspect of the role:

• cGMP and GDP
• BSL-2 biosafety and contamination control
• Deviation, CAPA, change control and audit readiness support

Application Deadline: 31 July 2026

If you do not receive a response from us within three weeks after closing date, 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.’’