Analytical Method Development Group Leader

4 days ago

Cape Town, South Africa SciStaff Full time

PhD or MSc with at least 5 years’ experience in the vaccine, biotech or pharmaceutical industry and 2 years’ supervisory experience in product development or a cGMP environment.*_
- Location:

- Cape Town
- Description:

- A leading vaccine manufacturer is looking for an Analytical Method Development (AMD) Group Leader to join their goal-oriented Science and Innovation team. The responsibilities 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 the group/ unit/ team; follow cGMP guidelines and ensure all Change Controls/ NCR’s etc. are effectively managed to support QA’s processes; 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 Analytical Method Development (microbial, immunological, chemical) and 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; managing Deviations, Change Controls, CAPAs; ensure timely and effective communication and escalate quality issues to the appropriate levels of management.
- Key Requirements:

- Additional Requirements:

- Knowledge of GDP and IP management and experience in technology transfer as well as successfully facing local quality audits is preferred.

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