Science & Innovation Senior Scientist

2 weeks ago

Cape Town, South Africa SciStaff Full time

*_ _PhD or MSc with at least 1-2 years’ Analytical method development experience in the vaccine, biotech or pharmaceutical industries*_

**Location**:

- Cape Town
- Description:

- A leading vaccine manufacturer is seeking a Senior Scientist to join their Science and Innovation team. The duties will include, but are not limited to, 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 upon; 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); driving Innovation and Continuous Improvement, Quality Risk Management and quality objectives and managing Deviations, Change Controls and CAPAs.
- Key Requirements:

- PhD or MSc with at least 1-2 years’ experience in Analytical method development in the vaccine, biotech or pharmaceutical industry or equivalent. Minimum of 1 year’s supervisory experience in product development or in a cGMP environment. Exposure and understanding of scientific principles that governs production of vaccines and biologicals, knowledge of Quality and regulatory compliance, i.e., MCC and WHO, and knowledge of cGMP (SA, PIC, WHO) and GLP guidelines are required.
- Additional Requirements:

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