The Biovac Institute requires a Production Manager to contribute to its mission of establishing local biological and vaccine manufacturing capability at its Cape Town based site. Being the only one of its kind in South Africa and gearing towards commercialization, Biovac strives to respond to the vaccine needs of the developing countries, specifically South Africa and Sub-Saharan Africa. This is a particularly exciting time for the company as it continues to grow, strengthen and build on its success and further develop its capabilities, products, services and market diversification.
The successful incumbent will report to the Chief Operations Officer (COO).
The Key Performance Areas for this position include:
- Full accountability and responsibility for Production strategic and operational activities, including Formulation, Filling (vials and syringes), Visual Inspection, Labelling and Packaging.
- Ensure that the manufacture and processing of vaccines and other products are produced within company-defined compliance, volumes and budgeted timeframe.
- Ensure that all processes pertaining to the manufacture and processing of products are according to consistent quality levels that align with GMP standards as laid down by MCC, WHO and/ or any other relevant controlling body to prevent high risk losses.
- Provide technological and process input into product manufacturing, equipment, techniques, facility requirements, quality requirements, logistics processes, test methods and commercial manufacturing practices.
- Ensure undisrupted, punctual and safe operation of staff and processes pertaining to Production and the company’s operations.
- Achieving/ maintaining of the facilities and processes in full compliance with the current regulations and guidelines – both local and international.
- Responsible for allocated project deliverables to Production, participating in projects and supporting other relevant organizational departments.
- Responsible to ensure that the Production department and its respective sections deliver services and solutions in alignment with pharmaceutical quality system requirements.
Core Technical Delivery
- Improvement and to provide technological and process input into product manufacturing, equipment, techniques, facility requirements, quality requirements, logistics processes, test methods and manufacturing practices.
- Products are produced and stored according to the appropriate documentation in order to obtain the required quality.
- Complex infrastructure and environment for aseptic processes for the high value products are maintained.
- Production records are evaluated and signed by an authorised person before they are sent to the Quality Control Department.
- Appropriate performance testing and validations are done.
- Ensuring that initial and continues training of department personnel is carried out and adapted according to need.
- Authorization of written procedures and other documents, including amendments.
- Monitoring and control of the manufacturing environment including plant hygiene and cleanliness.
- Approval and monitoring of suppliers of materials and contract manufacturers.
- Designation and monitoring of storage conditions for materials and products / protection of products and materials against spoilage and deterioration.
- Monitoring of compliance with the requirements of GMP and retention of all Production records.
- Inspection, investigation, and taking of samples, in order to monitor factors, which may affect product quality.
- Supporting Biovac in localising vaccine manufacturing skills development and expanding on this continuously.
- Check the maintenance of the department, premises and equipment and ensure optimal operations at all time.
Business Management
- Shared accountability for achieving the site’s tactical plans and mitigation of any risk to the site operation including workflow, ethics, quality, finances, regulatory compliance and other material company requirements.
- Identify and continuously present key opportunities and synergies that will improve and/ or expand the operation within own and/ or other departments.
- Lead or participate in departmental and/ or site wide projects.
- Monitoring & reporting on key operations, critical numbers and key performance indicators that impact the business’s short, medium and long-term objectives.
- Participate with the site management team in proactively mitigating risks and find solutions where possible.
- Effective and comprehensive costing, budgeting and expense management, considering all overlapping site activities.
- Lead own departments transition into commercial operations and mind-set as well as instituting this across site with regards to managing efficiencies, reducing wastage and contributing to overall profitability.
- Responsible to develop and maintain a 3-year rolling plan to effectively operationalise the company strategy as defined by Biovac board and executive team.
Technical Competencies required to perform this role:
- Excellent understanding and working knowledge of Commercial Production of biologicals (vaccines and others).
- Detailed knowledge of pharmaceutical industry standards and guidelines in GMP, Quality and Manufacturing.
- Documentation and Inventory Management.
- Environmental, Health & Safety Management.
- Statistical Trending & Data Analysis.
- Metric Development & Report Writing.
- Coaching & Mentoring of peers & staff.
- Review & Auditing Skills.
- Implementation, Monitoring and Review of Commercial Aseptic Manufacturing.
- Intermediate proficiency in Microsoft Word, Excel, Power point and Project.
- Metric & KPI development.
- Technical Report Writing.
- Operational Costing & Budgeting.
- User knowledge of SAP enterprise resource planning software.
Quality Management
- Building own, team and site’s GMP Knowledge and Compliance
- Participate in building quality objectives and provide ongoing metrics that directly support the achievement of such objectives.
- Participate in building a sustainable Quality Culture on site and proactive mitigate risks that may negatively impact quality or escalate these appropriately.
- Establish and maintain a state of control related to quality management within the department.
- Ensuring that the department is audit ready through closing out audit findings timeously
- Ensure Deviations, Change Controls, CAPAs are handled effectively
- Advocate continuous improvement within own department as well as cross functionally
- Ensure a state of accuracy across all documentation within own span of control in support of achieving optimal quality across Biovac.
- Ensure that the 4-eye principle is maintained when reviewing documentation.
Generic Competencies required to perform this role:
- Planning, Organising, Execution & Delegation
- Strategic & Holistic Thinking
- Creative Problem Solving & Innovation Skills
- Sustainable Stakeholder Management
- Financial Acumen and Commercial Awareness
- Action & Results Oriented
- Assertive & Resilient
- Adaptable in Responding to change
- Negotiation and influencing skills
- Proactive in mitigating risk
- Clear, timely and effective communication skills both verbally and in writing
- Analytical Ability
- Maintain confidentiality and trust
- Ethical leadership
Qualifications and Skills Required:
- Bachelor’s Degree or Diploma in Biotechnology/Microbiology/Chemistry, Pharmacy or equivalent.
- Recognition is given to Prior Learning and practical experience.
- At least 8 years experience in established vaccine/ biotech industry or equivalent of which 3 years at middle to senior management level.
- Aseptic manufacturing and quality management systems within a cGMP facility.
- Business and operational planning (incl. project management).
- Participation in developing a departmental budget and monitoring expenditures for multiple projects & funding sources.
- Faced successful local and/ or international regulatory audits.
- General business management within a commercial environment.
- Knowledge of Pharmaceutical Manufacturing related legislatio
All positions will be filled in accordance with our Employment Equity policy as The Biovac Institute is committed to the pursuit of excellence, diversity and redress. Interested persons to kindly submit their CV’s to www.biovac.co.za/register-and-apply-today by 07 August 2017.