Senior Scientist at Biovac

The Biovac Institute requires a Senior Scientist 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, 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 S&I Group Leader.

Job Purpose

• Responsible to lead the Analytical Method Development (AMD), Micro & Immunology platform (CMC - Chemistry, Manufacturing and Control) within S&I including but not limited to:
• Managing the AMD Micro/Immuno Technical team as well as act as the Analytics lead on to designated projects to generate business benefits, including product development and technology development.
• Overseeing the successful delivery of AMD Immunology deliverables with respect to CMC of S&I projects.
• Building strong Science and Innovation capability with respect to technology and associated platforms to support product development, technology transfers and manufacturing activities.
• Exploring strategically aligned Science and Innovation project opportunities.
• National and international networking and profiling of Biovac capability.
• Ensure undisrupted, punctual, and safe operation of staff and processes pertaining to research and development activities and the company’s operation.
• Ensure 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.
• Continuously build and support a sound quality assurance culture aligned to cGMP within Biovac.

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.
• 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 and documented delegation of ongoing operational activities in the event of key staff members’ absence in line with the related policies and SOP’s.
• Conduct effective employee relations in accordance with labour legislation, company policies and procedures and address any performance and conduct concerns and risks timeously.
• Ensure that occupational and other risks related to roles within the department are defined and mitigated.

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 impacts 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, taking all overlapping site activities into consideration.

Core Technical Delivery

• Laboratory Administration including Budgeting and Cost Control (Assists with group/ unit budgeting, follows a cost-conscious culture within own department/ group/ unit)
• Ensure services are delivered to all internal and/ or external stakeholders as defined and as per agreed timelines.
• Risk and Anticipation Mitigation to ensure that all work done is in accordance with current standards/processes and assist Senior Scientist/Scientist to identify anticipated risks impacting group/ unit/ team.
• Follow cGMP guidelines and ensure all Change Controls/ NCR’s etc. are effectively managed to support QA’s processes.
• Mitigate obvious risks on site and submit job cards to address facility issues/ risks as per the process set by Engineering.
• Close all actions assigned to self/ staff member as per EHS committee agreed deadlines.
• Responsible for providing assistance, guidance, problem solving or input to the operational departments as required and agreed.
• Responsible and accountable for the generation of applicable documentation in accordance with current scientific, GMP and GDP guidelines.
• Responsible for biological product and process development, which could include upstream (microbial cultivation) and down- stream processes (purification) and analytical method development (microbial, immunological, chemical).
• Responsible for experimental design, planning, execution, problem solving and recording.
• Accountable for specified deliverables within projects according to agreed timelines.
• Assist with technology transfers from development to manufacturing (including manufacture of material to be used in clinical trials).
• Responsible and accountable for the generation of applicable documentation in accordance with current scientific, GMP and GDP guidelines.
• Drive Innovation and Continuous Improvement
• Drive Quality Risk Management
• Manage Deviations, Change Controls, CAPAs
• Quality Objectives: Drive the quality objectives.
• Communication:

Ensure a timely and effective communication.

Escalate quality issues to the appropriate levels of management.

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 and proactive mitigate risks that may negatively impact quality or escalate these appropriately.
• Ensure Deviations, Change Controls, CAPAs are handled effectively.
• Advocate continuous improvement within own department as well as cross functionally.

Technical Competencies required to perform this aspect of the role:

• Risk Management
• cGMP vaccine manufacturing- quality and regulatory compliance knowledge, i.e. MCC and WHO
• Scientific/ Technical report writing.
• Good working knowledge of Microsoft office
• Quality management Systems
• Detailed knowledge of pharmaceutical industry standards and guidelines in GMP.
• Documentation Management
• Inventory Management
• Environmental, Health & Safety Management
• Statistical Trending & Data Analysis
• Metric Development & Report Writing
• Coaching & Mentoring of peers & staff
• Review & Auditing Skills
• cGMP vaccine manufacturing- quality and regulatory compliance knowledge, i.e. MCC and WHO
• Total Quality Management & Quality Management Systems
• Data development, trending & reporting.

Generic Competencies required to perform this aspect of the role:

• Attention to detail.
• Verbal and written communication and report writing
• Compliance orientation
• Strong problem solving and troubleshooting.
• Excellent organizational and coordination skills.
• Project planning, implementation, execution and close out skills.
• Flexibility and adaptability in responding to change.

Experience & industry accreditation/ knowledge.

Requird:

• 2 Years’ experience in analytical method development of vaccine / biotech / pharmaceutical industry or equivalent would be advantageous.
• 1 Year supervisory experience in product development or a cGMP environment.
• Exposure and understanding of scientific principles that governs production of vaccines and /or biologicals.